Alpha-1-proteinase inhibitor
- Generic Name
- Alpha-1-proteinase inhibitor
- Brand Names
- Aralast, Glassia, Prolastin, Prolastin-C, Respreeza, Zemaira
- Drug Type
- Biotech
- CAS Number
- 9041-92-3
- Unique Ingredient Identifier
- F43I396OIS
- Background
Human alpha-1 proteinase inhibitor or alpha-1-antitrypsin, prepared from human plasma via Cohn alcohol fractionation followed by PEG and zinc chloride fractionation.
- Indication
For chronic augmentation and maintenance therapy in individuals with alpha1-proteinase inhibitor (A1-PI) deficiency and clinical evidence of emphysema.
- Associated Conditions
- Emphysema
- Associated Therapies
- Augmentation, Maintenance therapy
Dose-Ranging Safety and Efficacy Study of Topical Creams Containing API 31510 for the Treatment of in Situ Cutaneous Squamous Cell Carcinoma
- First Posted Date
- 2008-01-31
- Last Posted Date
- 2012-07-25
- Lead Sponsor
- BPGbio
- Registration Number
- NCT00605709
Dose-Ranging Clinical Trial of Topical Creams Containing API 31510 for the Treatment of Superficial Basal Cell Carcinoma
- Conditions
- Superficial Basal Cell Carcinoma
- Interventions
- First Posted Date
- 2008-01-30
- Last Posted Date
- 2025-02-28
- Lead Sponsor
- BPGbio
- Target Recruit Count
- 186
- Registration Number
- NCT00604890
- Locations
- 🇺🇸
Colorado Medical Research Center, Denver, Colorado, United States
🇺🇸Dermatology Associates and Research, Coral Gables, Florida, United States
🇺🇸Dermatology Clinical Research Center of San Antonio, San Antonio, Texas, United States
Deposition of Inhaled Prolastin in Cystic Fibrosis Patients
- First Posted Date
- 2007-06-15
- Last Posted Date
- 2014-08-21
- Lead Sponsor
- Grifols Therapeutics LLC
- Target Recruit Count
- 72
- Registration Number
- NCT00486837
Aralast alpha1-proteinase Inhibitor Surveillance Study
- Conditions
- Alpha1-antitrypsin Deficiency
- First Posted Date
- 2006-04-12
- Last Posted Date
- 2021-05-26
- Lead Sponsor
- Baxalta now part of Shire
- Target Recruit Count
- 127
- Registration Number
- NCT00313144
- Locations
- 🇺🇸
Adupa Rao, MD, San Marino, California, United States
The Safety and Tolerability of Alpha-1 Modified Process (MP) In Subjects With Alpha-1-antitrypsin (AAT) Deficiency
- Conditions
- Alpha 1-Antitrypsin Deficiency
- Interventions
- First Posted Date
- 2006-03-10
- Last Posted Date
- 2014-08-19
- Lead Sponsor
- Grifols Therapeutics LLC
- Target Recruit Count
- 38
- Registration Number
- NCT00301366
- Locations
- 🇺🇸
University of Florida College of Medicine, Gainesville, Florida, United States
🇺🇸Cleveland Clinic Foundation, Cleveland, Ohio, United States
🇬🇧University of Cambridge - Cambridge Institute for Medical Research, Cambridge, England, United Kingdom
Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults
- Conditions
- Alpha 1-Antitrypsin Deficiency
- Interventions
- Drug: Alpha-1 MP
- First Posted Date
- 2006-02-22
- Last Posted Date
- 2014-09-09
- Lead Sponsor
- Grifols Therapeutics LLC
- Target Recruit Count
- 24
- Registration Number
- NCT00295061
- Locations
- 🇺🇸
National Jewish Medical and Research Center, Denver, Colorado, United States
🇺🇸St Lukes-Roosevelt Hospital Center, New York, New York, New York, United States
🇺🇸Cleveland Clinic Foundation, Cleveland, Ohio, United States
Alpha-1-Antitrypsin (AAT) To Treat Emphysema In AAT-Deficient Patients (EXACTLE)
- Conditions
- Alpha 1-Antitrypsin Deficiency
- Interventions
- Drug: Albumin (Human) 20%, United States Pharmacopeia (USP)
- First Posted Date
- 2005-12-09
- Last Posted Date
- 2014-08-21
- Lead Sponsor
- Grifols Therapeutics LLC
- Target Recruit Count
- 77
- Registration Number
- NCT00263887
- Locations
- 🇩🇰
Gentofte Hospital Department of Respiratory Medicine, Hellerup, Denmark
🇸🇪Department of Pulmonary Medicine, Malmö University Hospital, Malmö, Sweden
🇬🇧Queen Elizabeth Hospital, Birmingham, England, United Kingdom
Effects of Topical SLPI on Skin Wounds
- Conditions
- HealthyWound Healing
- First Posted Date
- 2000-04-24
- Last Posted Date
- 2008-03-04
- Lead Sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Target Recruit Count
- 60
- Registration Number
- NCT00005569
- Locations
- 🇺🇸
National Institute of Dental And Craniofacial Research (NIDCR), Bethesda, Maryland, United States
Drug Development Updates
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