An Open-Label, Multicenter, Randomized, Non-Inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Weekly Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Patients With Alpha1-Antitrypsin Deficiency Compared to Corresponding Standard 60 mg/kg/Week and 120 mg/kg/Week Doses of Intravenous Alpha1-Proteinase Inhibitor (5%)

This study is designed to compare two different weekly doses of a medicine called Alpha1-Proteinase Inhibitor given by injection under the skin with the standard doses of the same medicine given through a vein.
Adults with Alpha-1 Antitrypsin Deficiency will take part. Participants will be randomly assigned to one of the treatment groups, and both the study doctors and participants will know which treatment is being given.
The main goals of the study are to understand how the body processes the medicine (pharmacokinetics) and to assess how safe and well tolerated the different weekly doses are.

开始日期2026-05-05

申办/合作机构

Grifols Therapeutics LLC

CTIS2024-517613-33-00

/ Recruiting临床2期IIT

A two-center, randomized, double-blind, placebo-controlled study of intravenous plasma-purified alpha-1 antitrypsin for hospitalized patients with COPD exacerbations (AECOPD study)

开始日期2025-10-16

申办/合作机构

Fondazione IRCCS Policlinico San Matteo

NCT07125664

/ Not yet recruiting临床2期IIT

A Two-center, Randomized, Double-blind, Placebo-controlled Study of Intravenous Plasma-purified Alpha-1 Antitrypsin for Hospitalized Patients With COPD Exacerbations (AECOPD Study)

Intravenous augmentation therapy with purified preparations of AAT (Alpha1-antitrypsin) derived from human plasma is a well consolidated specific therapeutic option to treat the severe deficient state of AAT. Prolastin is used to restore the balance between AAT and elastases in the lung and consequently to prevent a further deterioration in the pulmonary emphysema. Recently, in patients with COVID-19, without genetically lowered AAT levels with moderate to severe ARDS, treatment with AAT was demonstrated to be safe, feasible, and biochemically efficacious as an anti-inflammatory therapeutic therapy.
The aim of the study, based on biological plausibility, is to evaluate the safety and efficacy (from a biological perspective) of the administration of intravenous plasma-purified AAT as an anti-inflammatory treatment for patients admitted to hospital because of a COPD exacerbation leading to an acute or an acute on chronic respiratory failure.
Thirty-six adult patients hospitalized because of a COPD exacerbation leading to an acute or an acute on chronic respiratory failure will be enrolled by the two sites involved in the study, the Pneumology Unit of Fondazione IRCCS Policlinico San Matteo (Pavia, Italy) and the Pneumology Unit of IRCCS Istituto Clinico Humanitas, Rozzano (Milano, Italy).
Participants will be randomized 2:1 in the active treatment group (standard treatment + IV administration of Prolastin) or in the placebo group (standard treatment+ IV administration of 0.9% sodium chloride).
To address the clinical question from a biological perspective, we will investigate the decrease in inflammatory markers in the active treated group in comparison with the placebo group.
The primary objective is to demonstrate a significant reduction in systemic inflammation by IV Prolastin administered once at 120 mg per kilogram of body weight in patients with moderate to severe AECOPD, as assessed by the change in plasma concentration of IL6 at 7 days after randomization, in the active treatment group with respect to placebo group.
Secondary outcomes are:
1. Difference in change in plasma concentration of IL-1b, IL-5, IL-8, IL-10, and soluble TNF receptor 1 (sTNFR1), CRP at 7 days after randomization.
2. Differences in AAT antielastase activity, the amount of active elastase, the AAT levels in serum at baseline and at 7 days after randomization.
3. Difference in treatment failure rate. Treatment failure is a composite endpoint of need for either NIV or CPAP or need of ETI or need of transfer to ICU or in-hospital death after randomization
4. Impact of AECOPD on overall health, daily life, and perceived well-being in patients with obstructive airways disease by the change of St. George's Respiratory Questionnaire (SGRQ) score from Day 7 to follow-up (30 days after hospital discharge).
5. Differences in type and number of AEs and SAEs in the two groups
The expected duration of subject participation is from randomization to 30 days after hospital discharge, with a follow up phone contact.

开始日期2025-10-01

申办/合作机构-

100 项与 Alpha1-proteinase inhibitor(Grifols SA) 相关的临床结果

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项与 Alpha1-proteinase inhibitor(Grifols SA) 相关的文献（医药）

2026-12-01·MOLECULAR BIOLOGY REPORTS

The role of nitric oxide and connexin 43 in the cardioprotective effects of apigenin against doxorubicin-induced cardiotoxicity in male rats

Article

作者: Dehpour, Ahmad Reza ; Azizi, Yaser ; Goudarzi, Mina ; Safaei, Atlasi ; Fallah, Masoud ; Sheibani, Mohammad

BACKGROUND:

Doxorubicin (DOX) is one of the most widespread antibiotics used in the treatment of malignancies. Cardiotoxicity is the main side effect of DOX. Although the protective effects of apigenin have been shown, its mechanisms are still unknown. This study aimed to assess the role of nitric oxide (NO) in the protective effects of apigenin, particularly by altering the expression of connexin 43 (CX43) in the heart tissue.

METHODS AND RESULTS:

In this study, 60 male Wistar rats were divided into six equal groups: control (normal), DOX (2 mg/kg every 48 h for 12 days i.p.), apigenin (Api, 50 mg/kg oral administration), DOX + Api, DOX + L-NAME (Nitro-L-arginine methyl ester) (30 mg/kg i.p.), and DOX + Api + L-NAME. Our study assessed alterations in the heart weight and body weight, markers of cardiac function via echocardiography Ejection Fraction (%EF), Fractional Shortening (%FS), Left Ventricular Internal Diameter in Systole (LVIDs), and Left Ventricular Internal Diameter in Diastole (LVIDd), cardiac oxidative stress factors Superoxide Dismutase (SOD), Reduced Glutathione (GSH), Malondialdehyde (MDA), Catalase (CAT), cardiac injury markers Lactate Dehydrogenase (LDH), Creatine Kinase-MB (CK-MB), and Cardiac Troponin I (cTn-I), cardiac fibrosis, and CX43 expression (immunohistochemistry). Apigenin improved cardiac tissue damage and functional parameters such as left ventricular EF. Furthermore, treatment with apigenin, but not DOX, caused a significant reduction in the percentage of cardiac fibrosis and oxidative stress activity. Apigenin can also elevate the cardiac CX43 expression in the DOX + Api compared to the DOX group. NOS inhibition by L-NAME attenuates the protective effects of apigenin in DOX-induced cardiotoxicity COCCLUSION: Apigenin could exert its cardioprotective effects through an NO-dependent mechanism and elevation of CX43 expression.

2026-08-01·JOURNAL OF NUTRITION

Protective Effect of Apiaceous Vegetables against Total Western Diet- and Dextran Sulfate Sodium-Induced Colitis in Mice

Article

作者: Ibarra, Laura E ; Zhao, Jiangchao ; Trudo, Sabrina P ; Read, Quentin D ; Chen, Chi ; Yeruva, Laxmi ; Zuo, Bin ; Gurung, Manoj ; Lee, Hee-Seop ; Fox, Renee

BACKGROUND:

Western-style dietary patterns are associated with colitis and colon cancer. Existing data indicate that intake of apiaceous (API) vegetables (e.g., celery, parsnip) may prevent inflammation-associated diseases.

OBJECTIVES:

We investigated in mice the effect of API supplementation to the total Western diet (TWD) against dextran sulfate sodium-induced colitis.

METHODS:

Male C57BL/6J mice (8-wk-old; 15 per group) were fed TWD supplemented with 21% or 42% fresh API (wt/wt) and given 2% dextran sulfate sodium to induce colitis. Diet intake, body weight, and disease activity index were monitored. Serum was collected for cytokine/chemokine analysis and colonic tissues for histology and Western blot. Fecal samples were analyzed by 16S ribosomal ribonucleic acid gene sequencing and targeted/untargeted metabolomics. Phenotypic data were analyzed by analysis of variance with Tukey's test. Microbiome data were centered log-ratio (CLR) transformed and analyzed using linear mixed models with adjusted pairwise comparisons.

RESULTS:

API supplementation attenuated colitis phenotypes including weight loss (44% recovery; P < 0.001), colon shortening (57% recovery; P < 0.01), disease activity (59% lower; P < 0.001), cytokine/chemokine release (35%‒73% reductions; P < 0.05), and mucosal F4/80+ cells infiltration (80% reduction; P < 0.001). API also improved gut microbiota diversity and composition, increasing α diversity metrics (4.4%‒13.8%; P < 0.05), suppressing pathogenic bacteria (Paraclostridium, Enterococcus, Eubacterium; estimated CLR difference: -1.8 to -6.7; P < 0.001), and enriching beneficial bacteria (Lachnospiraceae and Blautia; estimated CLR difference: +1.6 to +3.0; P < 0.05). Furthermore, metabolomics indicated TWD consumption increased arachidonic acid and aliphatic aldehydes (by 109%‒510%; P < 0.001), and decreased short-chain and unsaturated fatty acids (by 30%‒91%; P < 0.001). API supplementation also mitigated TWD-derived functional metabolites (including bile acids; P < 0.05).

CONCLUSIONS:

These data indicate that API intake is beneficial for risk reduction of diseases associated with Western diets. However, further investigations are warranted to determine the mechanism behind these beneficial effects.

2026-08-01·AIDS

The estimated cost of MK-8527 produced at scale for once-monthly oral HIV pre-exposure prophylaxis in low- and middle-income countries

Article

作者: Cross, Samuel ; Hill, Andrew ; Levi, Jacob ; Venter, Francois

The objectives were to estimate the potential generic production cost of MK-8527, a novel once-monthly oral nucleoside reverse transcriptase translocation inhibitor (NRTTI) in development for HIV preexposure prophylaxis (PrEP), and to assess implications for cost-effectiveness and access in low-income and middle-income countries (LMICs). A cost estimation study using shipment level active pharmaceutical ingredient (API) data and established cost+ modelling methods to project scalable generic production pricing was performed. The Trade Vision LLC database was searched (January 2020 to December 2025) for records of MK-8527 API exports to India. A weighted mean API cost was calculated and combined with annual dosing assumptions (11 mg/month). Standardized cost+ components were applied, including formulation, API loss, packaging, transportation and tariffs, profit margin, and taxation. Sensitivity analyses explored variation in API pricing. Three API shipments were identified, yielding a weighted mean API cost of $9878/kg. Estimated generic production cost for monthly PrEP dosing was $4.49 per person-year (ppy). Sensitivity analyses produced a range of $4.46–$24.91 ppy. These estimates are substantially below published PrEP cost-effectiveness thresholds of approximately $100 ppy in sub-Saharan Africa and up to $200 ppy in high-incidence settings. MK-8527 could be manufactured at extremely low cost, suggesting that intellectual property and licensing arrangements, rather than production feasibility, will determine equitable access in LMICs. Early voluntary licensing agreements could facilitate timely generic entry and affordable global scale-up if clinical efficacy is confirmed.

项与 Alpha1-proteinase inhibitor(Grifols SA) 相关的新闻（医药）

2026-08-15

·BioSpace

Grifols Announces Last Patient Last Visit in SPARTA, its Phase 3 Outcomes Study of Prolastin®-C in Patients With Emphysema Due to Alpha-1 Antitrypsin Deficiency

Grifols’ SPARTA phase 3 trial is designed to evaluate the clinical efficacy and safety of two separate weekly dose regimens of Grifols’ Prolastin ®-C (Alpha1-Proteinase Inhibitor [Human] modified process) in patients with emphysema due to alpha-1 antitrypsin (AAT) deficiency (known as alpha-1) The trial is the largest randomized, double-blind, placebo-controlled study on alpha-1 and augmentation therapy to-date and has the potential to provide clinical evidence on slowing progression of lung tissue loss in this patient group This milestone marks the completion of follow-up for all 345 participants enrolled across 37 sites in 16 countries Top line results expected by the end of 2026 Grifols continues to advance scientific innovation in alpha-1 through a comprehensive approach that includes disease awareness, genetic testing, clinical research and treatment Aug. 10, 2026 -- Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global healthcare company and leading producer of plasma-derived medicines, today announced the completion of the clinical portion of SPARTA (Study of ProlAstin-C Randomized Therapy with Alpha-1 augmentation; NCT01983241), its phase 3 outcomes study evaluating the clinical efficacy and safety of two dose regimens of Prolastin®-C (Alpha1-Proteinase Inhibitor [Human] modified process) in patients with emphysema associated with alpha-1 antitrypsin deficiency (AATD), also known as alpha-1. The last patient in the trial completed their final study visit last week. This milestone, known as “last patient, last visit” (LPLV) signifies completion of follow-up for all 345 enrolled participants. Topline results are expected by the end of this year. Alpha-1 is a genetic disorder that can result in chronic obstructive pulmonary disease (COPD), a group of respiratory diseases that include emphysema, which can occur when a patient has low levels of AAT, a protective protein that safeguards the lungs. Alpha-1 remains significantly underdiagnosed1 worldwide despite being the most common known genetic risk factor for COPD.】】 SPARTA is the largest randomized, double-blind, placebo-controlled study conducted to date in augmentation therapy for alpha-1 patients with emphysema. The trial was designed to evaluate the efficacy and safety of weekly administration of two active dose levels of Prolastin-C (60 mg/kg and 120 mg/kg) compared with placebo over a three-year treatment period. The study was conducted across 37 clinical sites in 16 countries and used whole-lung computed tomography (CT) densitometry as its primary efficacy endpoint. CT densitometry is considered the most sensitive method for detecting emphysema progression and quantifying lung tissue loss in patients with AATD2, making SPARTA the first and only three-year study in AATD to generate longitudinal clinical evidence using this biomarker. “The completion of patient follow-up in SPARTA marks a significant milestone for Grifols and the alpha-1 community,” said Eduardo Herrero, Grifols’ Executive Vice President Biopharma Industrial and Scientific Innovation. “We are deeply grateful to the patients, investigators and study teams whose dedication made this achievement possible. As the first and only prospective, double-blind, placebo-controlled three-year CT densitometry study in alpha-1-related emphysema, SPARTA reflects our long-standing commitment to people living with alpha-1 through innovation in testing, diagnosis and treatment.” In addition to the SPARTA study, Grifols recently began the SWIFT-SC trial (NCT07555483), the first Phase 3 trial evaluating a weekly subcutaneous alpha1-proteinase inhibitor for the treatment of AATD. These clinical trials demonstrate the company’s ongoing commitment to innovation and to improving therapeutic options and long-term outcomes for patients with alpha-1. Alpha-1-antitrypsin deficiency, also known as alpha-1, is a rarely diagnosed genetic disease that can result in chronic obstructive pulmonary disease (COPD), a group of respiratory diseases that includes emphysema, a lung condition that causes shortness of breath. Patients who have alpha-1 have a genetic deficiency of alpha-1 antitrypsin, a protective plasma protein that safeguards the lungs from inflammation caused by infection and inhaled irritants such as tobacco smoke. Alpha-1 is the major known genetic risk factor for COPD3. PROLASTIN®-C is an alpha1-proteinase inhibitor (human) (alpha1-PI) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of alpha1-PI (alpha-1-antitrypsin deficiency). The effect of augmentation therapy with any alpha1-PI, including PROLASTIN-C LIQUID, on pulmonary exacerbations and on the progression of emphysema in alpha1-PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials Clinical data demonstrating the long-term effects of chronic augmentation or maintenance therapy with PROLASTIN-C LIQUID are not available PROLASTIN-C LIQUID is not indicated as therapy for lung disease in patients in whom severe alpha1-PI deficiency has not been established PROLASTIN-C is contraindicated in immunoglobulin A (IgA)-deficient patients with antibodies against IgA or patients with a history of anaphylaxis or other severe systemic reaction to alpha1-PI products. Hypersensitivity reactions, including anaphylaxis, may occur. Monitor vital signs and observe the patient carefully throughout the infusion. If hypersensitivity symptoms occur, promptly stop PROLASTIN-C infusion and begin appropriate therapy. Because PROLASTIN-C is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. This also applies to unknown or emerging viruses and other pathogens. The most common adverse reaction during clinical trials in > 5% of subjects was upper respiratory tract infection. The most serious adverse reaction observed during clinical trials with PROLASTIN-C was an abdominal and extremity rash in 1 subject. for Prolastin-C. Always refer to the Summary of Product Characteristics (SmPC) and the local prescribing information of your country. Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people around the world. A leader in essential plasma-derived medicines and transfusion medicine, the company develops, produces and provides innovative healthcare services and solutions in more than 110 countries. Patient needs and Grifols’ ever-growing knowledge of many chronic, rare and prevalent conditions, at times life-threatening, drive the company’s innovation in both plasma and other biopharmaceuticals to enhance quality of life. Grifols focuses on treating conditions centered on six core therapeutic areas: immunology, neurology, pulmonology, hematology, hepatology and intensive care. A pioneer in the plasma industry, Grifols continues to grow its network of donation centers, the world’s most diversified with more than 400 across North America, Europe, Africa and the Middle East, and China. The content above comes from the network. if any infringement, please contact us to modify. As a recognized leader in transfusion medicine, Grifols offers a comprehensive portfolio of solutions designed to enhance safety from donation to transfusion, in addition to clinical diagnostic technologies. It provides high-quality biological supplies for life-science research, clinical trials and for manufacturing pharmaceutical and diagnostic products. The company also supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care. Grifols, with more than 25,000 employees in more than 30 countries and regions, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety and ethical leadership. The company’s class A shares are listed on the Spanish Stock Exchange, where they are part of the IBEX-35 (MCE:GRF). Grifols non- voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS). _______________ 1 American Thoracic Society; European Respiratory Society. American Thoracic Society/European Respiratory Society statement: standards for the diagnosis and management of individuals with alpha-1 antitrypsin deficiency. Am J Respir Crit Care Med. 2003;168(7):818-900. doi:10.1164/rccm.168.7.818 2 Miravitlles M et al.European Respiratory Society statement: diagnosis and treatment of pulmonary disease in alpha-1 antitrypsin deficiency. Eur Respir J. 2017 3 Sandhaus RA, Turino G, Brantly ML, et al. The Diagnosis and Management of Alpha-1 Antitrypsin Deficiency in the Adult. J COPD Foundation. 2016;3(3):668-682. The content above comes from the network. if any infringement, please contact us to modify.

临床研究

2026-08-10

·grifols.com

Grifols announces Last Patient Last Visit in SPARTA, its Phase 3 Outcomes Study of Prolastin®-C in patients with emphysema due to alpha-1 antitrypsin deficiency

The information is aimed exclusively at authorized healthcare professionals to prescribe or supply medical products and its correct interpretation requires specialized training. Are you a healthcare professional? Grifols’ SPARTA phase 3 trial is designed to evaluate the clinical efficacy and safety of two separate weekly dose regimens of Grifols’ Prolastin®-C (Alpha1-Proteinase Inhibitor [Human] modified process) in patients with emphysema due to alpha-1 antitrypsin (AAT) deficiency (known as alpha-1) The trial is the largest randomized, double-blind, placebo-controlled study on alpha-1 and augmentation therapy to-date and has the potential to provide clinical evidence on slowing progression of lung tissue loss in this patient group This milestone marks the completion of follow-up for all 345 participants enrolled across 37 sites in 16 countries Top line results expected by the end of 2026 Grifols continues to advance scientific innovation in alpha-1 through a comprehensive approach that includes disease awareness, genetic testing, clinical research and treatment Barcelona, Spain, August 10, 2026 – Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global healthcare company and leading producer of plasma-derived medicines, today announced the completion of the clinical portion of SPARTA (Study of ProlAstin-C Randomized Therapy with Alpha-1 augmentation; NCT01983241), its phase 3 outcomes study evaluating the clinical efficacy and safety of two dose regimens of Prolastin®-C (Alpha1-Proteinase Inhibitor [Human] modified process) in patients with emphysema associated with alpha-1 antitrypsin deficiency (AATD), also known as alpha-1. The last patient in the trial completed their final study visit last week. This milestone, known as “last patient, last visit” (LPLV) signifies completion of follow-up for all 345 enrolled participants. Topline results are expected by the end of this year. Alpha-1 is a genetic disorder that can result in chronic obstructive pulmonary disease (COPD), a group of respiratory diseases that include emphysema, which can occur when a patient has low levels of AAT, a protective protein that safeguards the lungs. Alpha-1 remains significantly underdiagnosed[1] worldwide despite being the most common known genetic risk factor for COPD. SPARTA is the largest randomized, double-blind, placebo-controlled study conducted to date in augmentation therapy for alpha-1 patients with emphysema. The trial was designed to evaluate the efficacy and safety of weekly administration of two active dose levels of Prolastin-C (60 mg/kg and 120 mg/kg) compared with placebo over a three-year treatment period. The study was conducted across 37 clinical sites in 16 countries and used whole-lung computed tomography (CT) densitometry as its primary efficacy endpoint. CT densitometry is considered the most sensitive method for detecting emphysema progression and quantifying lung tissue loss in patients with AATD[2], making SPARTA the first and only three-year study in AATD to generate longitudinal clinical evidence using this biomarker. “The completion of patient follow-up in SPARTA marks a significant milestone for Grifols and the alpha-1 community,” said Eduardo Herrero, Grifols’ Executive Vice President Biopharma Industrial and Scientific Innovation. “We are deeply grateful to the patients, investigators and study teams whose dedication made this achievement possible. As the first and only prospective, double-blind, placebo-controlled three-year CT densitometry study in alpha-1-related emphysema, SPARTA reflects our long-standing commitment to people living with alpha-1 through innovation in testing, diagnosis and treatment.” In addition to the SPARTA study, Grifols recently began the SWIFT-SC trial (NCT07555483), the first Phase 3 trial evaluating a weekly subcutaneous alpha1-proteinase inhibitor for the treatment of AATD. These clinical trials demonstrate the company’s ongoing commitment to innovation and to improving therapeutic options and long-term outcomes for patients with alpha-1. About Alpha-1 and COPD Alpha-1-antitrypsin deficiency, also known as alpha-1, is a rarely diagnosed genetic disease that can result in chronic obstructive pulmonary disease (COPD), a group of respiratory diseases that includes emphysema, a lung condition that causes shortness of breath. Patients who have alpha-1 have a genetic deficiency of alpha-1 antitrypsin, a protective plasma protein that safeguards the lungs from inflammation caused by infection and inhaled irritants such as tobacco smoke. Alpha-1 is the major known genetic risk factor for COPD[3]. About Prolastin®-C PROLASTIN®-C is an alpha1-proteinase inhibitor (human) (alpha1-PI) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of alpha1-PI (alpha-1-antitrypsin deficiency). Limitations of Use The effect of augmentation therapy with any alpha1-PI, including PROLASTIN-C LIQUID, on pulmonary exacerbations and on the progression of emphysema in alpha1-PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials Clinical data demonstrating the long-term effects of chronic augmentation or maintenance therapy with PROLASTIN-C LIQUID are not available PROLASTIN-C LIQUID is not indicated as therapy for lung disease in patients in whom severe alpha1-PI deficiency has not been established PROLASTIN-C is contraindicated in immunoglobulin A (IgA)-deficient patients with antibodies against IgA or patients with a history of anaphylaxis or other severe systemic reaction to alpha1-PI products. Hypersensitivity reactions, including anaphylaxis, may occur. Monitor vital signs and observe the patient carefully throughout the infusion. If hypersensitivity symptoms occur, promptly stop PROLASTIN-C infusion and begin appropriate therapy. Because PROLASTIN-C is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. This also applies to unknown or emerging viruses and other pathogens. The most common adverse reaction during clinical trials in > 5% of subjects was upper respiratory tract infection. The most serious adverse reaction observed during clinical trials with PROLASTIN-C was an abdominal and extremity rash in 1 subject. Please see full US Prescribing Information for Prolastin-C. Always refer to the Summary of Product Characteristics (SmPC) and the local prescribing information of your country. [1] American Thoracic Society; European Respiratory Society. American Thoracic Society/European Respiratory Society statement: standards for the diagnosis and management of individuals with alpha-1 antitrypsin deficiency. Am J Respir Crit Care Med. 2003;168(7):818-900. doi:10.1164/rccm.168.7.818 [2] Miravitlles M et al.European Respiratory Society statement: diagnosis and treatment of pulmonary disease in alpha-1 antitrypsin deficiency. Eur Respir J. 2017 [3] Sandhaus RA, Turino G, Brantly ML, et al. The Diagnosis and Management of Alpha-1 Antitrypsin Deficiency in the Adult. J COPD Foundation. 2016;3(3):668-682. Our media relations team can be reached at: (+34) 93 571 00 02 media@grifols.com. Restricted to media inquiries only. For general questions and requests, please contact corporatecomms@grifols.com. The information contained on the Grifols worldwide website is not applicable to all countries. For specific information on the products and services available in your country, please select your country from the list included in the corresponding section. The purpose of this website is to provide information about Grifols' products and services, and it is not intended for, nor may it be construed as, promoting any products in countries in which they are not approved.

临床3期

2026-06-29

·grifols.com

Grifols doses first participant in Phase 3 study evaluating novel subcutaneous therapy for alpha1-antitrypsin deficiency

First-of-its-kind Phase 3 study to evaluate weekly subcutaneous Alpha1-Proteinase Inhibitor, a novel approach, compared to standard intravenous therapy SWIFT-SC is an open-label, multicenter, randomized trial Positive outcome could expand treatment flexibility for patients Barcelona, Spain, June 29, 2026 – Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global healthcare company and leading producer of plasma-derived medicines, today announced the enrollment of the first patient in its Phase 3 SWIFT-SC clinical trial, a global study designed to evaluate a novel subcutaneous (SC) formulation of Alpha1-Proteinase Inhibitor (Alpha1-PI) for the treatment of alpha1-antitrypsin (AAT) deficiency. The SWIFT-SC study (NCT07555483) “An Open-Label, Multicenter, Randomized, Non-Inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Weekly Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Patients With Alpha1-Antitrypsin Deficiency Compared to Corresponding Standard 60 mg/kg/Week and 120 mg/kg/Week Doses of Intravenous Alpha1-Proteinase Inhibitor (5%)” will compare two different weekly doses of subcutaneous Alpha-15% with corresponding standard intravenous Alpha1-PI doses. The trial’s short name, SWIFT-SC, stands for Subcutaneous; Weekly dosing; Alpha1 proteinase Inhibitor Formulation-focused; clinical Trial – subcutaneous (SC), representing the aim of the study. The purpose of SWIFT-SC is to determine whether the subcutaneous formulation demonstrates non-inferior pharmacokinetics compared to intravenous therapy, while also evaluating safety and tolerability. Adult participants with AAT deficiency will be randomly assigned to two treatment groups in this open-label study. Advancing toward more flexible treatment options SWIFT-SC is the first Phase 3 clinical trial to evaluate subcutaneous augmentation therapy in patients with AAT deficiency. This trial builds on the successful completion of the Phase 1/2 study, NCT04722887, sponsored by Grifols. The investigational therapy uses a 15% concentration, approximately three times higher than the standard intravenous formulation, enabling delivery via subcutaneous administration. Subcutaneous administration of medicines may provide meaningful benefits for patients by enabling self-administration outside of clinical settings, reducing reliance on infusion centers or home healthcare visits, and providing greater flexibility in when and where treatment is administered. “Advancing treatment approaches is an important step forward for patients living with alpha1-antitrypsin deficiency,” said Eduardo Herrero, Grifols’ EVP Biopharma Industrial and Scientific Innovation. “With SWIFT-SC, we are exploring the potential to expand treatment options to deliver Alpha1-PI therapy in a way that best aligns with individual patient preferences.” Building on ongoing Alpha-1 research SWIFT-SC complements Grifols’ broader clinical program in AAT deficiency, including the ongoing SPARTA study (NCT01983241), which is the largest prospective, randomized, double-blind, placebo-controlled study to date designed to provide computed tomography (CT) densitometry efficacy data on the impact of plasma-derived augmentation therapy for AAT deficiency. SPARTA is expected to complete in the second half of this year, with top-line results anticipated by year-end. Together, these studies reflect Grifols’ commitment to advancing innovative therapeutic options and improving long-term outcomes for patients with AAT deficiency. About Alpha-1 and COPD Alpha-1-antitrypsin deficiency, also known as alpha-1, is a rarely diagnosed genetic disease that can result in chronic obstructive pulmonary disease (COPD), a group of respiratory diseases that includes emphysema, a lung condition that causes shortness of breath. Patients who have alpha-1 have a genetic deficiency of alpha-1 antitrypsin, a protective plasma protein that safeguards the lungs from inflammation caused by infection and inhaled irritants such as tobacco smoke. Alpha-1 is the major known genetic risk factor for COPD[1]. [1] What causes alpha-1 antitrypsin deficiency? National Heart, Lung, and Blood Institute website. https://www.nhlbi.nih.gov/health/health-topics/topics/aat/causes. Updated October 11, 2011. Accessed June 28, 2023. Our media relations team can be reached at: (+34) 93 571 00 02 media@grifols.com. Restricted to media inquiries only. For general questions and requests, please contact corporatecomms@grifols.com.

临床3期

100 项与 Alpha1-proteinase inhibitor(Grifols SA) 相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
-	Alpha1-proteinase inhibitor(Grifols SA)	B02AB02	DB00058

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适应症	国家/地区	公司	日期
α1-抗胰蛋白酶缺乏症	日本	OrphanPacific, Inc.	2021-01-22
肺气肿	美国	Grifols Therapeutics, Inc.	1987-12-02

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适应症	最高研发状态	国家/地区	公司	日期
HIV感染	临床3期	美国	Grifols Biologicals, Inc.	2012-04-01
新型冠状病毒感染	临床2期	西班牙	Instituto Grifols SA	2020-07-29
1型糖尿病	临床2期	美国	Grifols Therapeutics, Inc.	2014-03-01
囊性纤维化	临床2期	-	Grifols Therapeutics, Inc.	2003-12-01
气肿	临床2期	丹麦	Grifols Therapeutics, Inc.	2003-12-01
气肿	临床2期	瑞典	Grifols Therapeutics, Inc.	2003-12-01
气肿	临床2期	英国	Grifols Therapeutics, Inc.	2003-12-01

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适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02947087 (CTgov)	临床1/2期	慢性胰腺炎	48	Prolastin-C (Prolastin-C)	憲艱壓餘範顧膚餘窪顧(憲鏇構範範獵憲窪齋遞) = 醖蓋鏇餘構網積獵觸構鏇艱獵膚簾觸遞願憲範 (繭構構廠淵壓顧襯廠壓, 42) 更多	-	2023-05-09
				Placebo (Placebo)	憲艱壓餘範顧膚餘窪顧(憲鏇構範範獵憲窪齋遞) = 選築願蓋壓構遞選遞網鏇艱獵膚簾觸遞願憲範 (繭構構廠淵壓顧襯廠壓, 78) 更多
NCT04547140 (CTgov)	临床2期	新型冠状病毒感染	57	Standard Medical Treatment	壓製構構鹹觸壓鬱構築 = 範餘膚鑰艱鑰廠廠衊膚襯壓憲艱鹹壓憲獵築壓 (壓淵顧醖醖餘選鏇鹹鬱, 製蓋壓獵製構糧窪獵繭 ~ 願鑰積願觸淵鏇膚構憲) 更多	-	2023-03-22
JPRN-JapicCTI-163194 \| NCT02870348 (GTI1401-OLE, Pubmed \| Respir Investig) 人工标引	临床1/2期	α1-抗胰蛋白酶缺乏症	4	Alpha1-proteinase inhibitor	鹽鑰鬱鬱範膚壓醖鏇蓋(糧獵範鹽鹽艱願夢築構) = 鹽範齋顧簾獵醖餘壓選鹹製廠觸蓋衊觸夢壓蓋 (積網蓋窪夢鏇構廠窪鹹 ) 更多	积极	2022-08-12
NCT02870348 (GTI1401-OLE, CTgov)	临床1/2期	α1-抗胰蛋白酶缺乏症	4	Alpha-1 MP	醖齋憲選窪淵鏇願艱衊 = 製遞衊鏇襯顧願餘築繭窪積餘鹽壓醖鏇繭夢簾 (齋願選獵鬱鏇齋淵獵鏇, 繭顧淵夢夢築齋襯壓膚 ~ 襯夢積糧襯艱膚築壓廠) 更多	-	2022-03-21
NCT01731691 (CTgov)	临床2/3期	HIV感染	12	α1 Proteinase Inhibitor (α1 Proteinase Inhibitor in HIV Disease)	製糧鬱製簾觸鑰窪觸餘(窪艱壓製衊齋齋鬱獵鬱) = 廠餘憲觸淵鹽積衊網淵簾壓觸艱簾願鑰廠築壓 (簾鹹窪壓艱夢壓鹹齋簾, 103) 更多	-	2020-08-31
				Placebos (Placebo in HIV Disease)	製糧鬱製簾觸鑰窪觸餘(窪艱壓製衊齋齋鬱獵鬱) = 襯壓構繭構憲網選獵鏇簾壓觸艱簾願鑰廠築壓 (簾鹹窪壓艱夢壓鹹齋簾, 180) 更多
NCT02093221 (CTgov)	临床2期	1型糖尿病	76	180 mg/kg Alpha1-PI (Alpha1-PI 180 mg/kg/wk, 26 Weeks)	餘築範齋鹽範襯遞製製(艱築築範網醖齋築築膚) = 膚醖遞範壓積襯衊觸鏇醖選鏇膚齋網夢選鹹製 (淵繭襯願膚網願選製製, 27.7184) 更多	-	2018-04-19
				180 mg/kg Alpha1-PI (180 mg/kg/wk Alpha1-PI, 13 Weeks)	餘築範齋鹽範襯遞製製(艱築築範網醖齋築築膚) = 遞壓鹽襯餘構繭壓範衊醖選鏇膚齋網夢選鹹製 (淵繭襯願膚網願選製製, 28.9450) 更多
NCT02282527 (CTgov)	临床2/3期	α1-抗胰蛋白酶缺乏症	32	Liquid Alpha₁-PI+Alpha1-PI (Liquid Alpha₁-PI)	窪窪鑰鏇願積艱選鏇鬱(襯鏇齋廠膚窪鹽製簾襯) = 蓋窪衊淵構餘範遞齋壓蓋鹹鹽鑰繭艱鏇廠窪襯 (鏇鹹襯壓鏇網願膚製窪, 23.041) 更多	-	2017-03-13
				Prolastin-C (Prolastin-C)	窪窪鑰鏇願積艱選鏇鬱(襯鏇齋廠膚窪鹽製簾襯) = 遞構醖鏇醖廠膚鬱鑰憲蓋鹹鹽鑰繭艱鏇廠窪襯 (鏇鹹襯壓鏇網願膚製窪, 25.230) 更多
NCT01936896 (VCU-α1RT \| VCU-Alpha1RT, CTgov)	临床1/2期	ST段抬高心肌梗死 \| 急性心肌梗塞	10	Alpha 1-Antitrypsin	膚艱齋鏇醖廠顧製顧簾(艱膚範鹽鬱艱製鹹壓鑰) = 遞憲襯鏇醖繭憲衊鑰餘選繭餘廠廠壓遞範構醖 (鑰築齋範選構醖夢膚選, 襯鹽廠鑰窪膚襯鏇鑰繭 ~ 壓網觸憲獵鹽製獵廠範) 更多	-	2016-02-12
NCT01213043 (SPARK, CTgov)	临床2期	α1-抗胰蛋白酶缺乏症 \| 肺气肿	30	Prolastin-C (60 mg/kg Prolastin-C)	憲廠鹹襯構齋齋觸鹽鏇 = 醖蓋鹹選醖膚鑰顧願蓋構積襯觸艱積膚衊願鹽 (淵齋鏇積醖窪遞膚構鑰, 壓齋壓遞築鏇積夢範鏇 ~ 憲願鏇夢鹽鑰餘壓窪遞) 更多	-	2013-05-20
				Prolastin-C (120 mg/kg Prolastin-C)	憲廠鹹襯構齋齋觸鹽鏇 = 憲鬱選齋蓋範夢簾鏇鹹構積襯觸艱積膚衊願鹽 (淵齋鏇積醖窪遞膚構鑰, 醖鑰鑰夢憲鬱餘淵壓鹽 ~ 積壓憲衊壓壓齋廠糧鏇) 更多