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Alpha-1 MP

BIOLOGICAL5 trials

Sponsors

Grifols Therapeutics LLC

Conditions

Alpha 1-Antitrypsin DeficiencyAlpha1-Antitrypsin DeficiencyPulmonary Emphysema in Alpha-1 Antitrypsin DeficiencyPulmonary Emphysema in Alpha-1 PI Deficiency

Phase 1

Long-term Safety of Alpha1-Proteinase Inhibitor (Human) in Japanese Subjects With Alpha1 Antitrypsin Deficiency (GTI1401-OLE)
CompletedNCT02870348
Grifols Therapeutics LLCAlpha1-Antitrypsin Deficiency
Start: 2016-07-29End: 2021-02-16Updated: 2022-03-31
Safety and Pharmacokinetics of Alpha-1 MP (Alpha1-proteinase Inhibitor (Human), Modified Process) in Participants With Alpha1-Antitrypsin Deficiency
CompletedNCT02870309
Grifols Therapeutics LLCAlpha1-Antitrypsin Deficiency
Start: 2016-07-29End: 2017-03-15Updated: 2021-10-28

Phase 3

Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults
CompletedNCT00295061
Grifols Therapeutics LLCAlpha 1-Antitrypsin Deficiency
Start: 2006-05-31End: 2007-02-28Updated: 2014-09-09
Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)
Active, not recruitingNCT01983241
Grifols Therapeutics LLCPulmonary Emphysema in Alpha-1 PI Deficiency
Start: 2013-11-01End: 2027-01-01Updated: 2026-06-23
Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency
Enrolling by invitationNCT02796937
Grifols Therapeutics LLCPulmonary Emphysema in Alpha-1 Antitrypsin Deficiency
Start: 2016-07-01End: 2029-02-01Target: 290Updated: 2026-06-23

Related Papers

Long-term safety of Prolastin®-C, an alpha1-proteinase inhibitor, in Japanese patients with alpha1-antitrypsin deficiency
Respiratory Investigation2022-08-121 citations
Safety and pharmacokinetics of Alpha-1 MP (Prolastin<sup>®</sup>-C) in Japanese patients with alpha<sub>1</sub>-antitrypsin (AAT) deficiency.
2018-11-085 citations
SPARTA clinical trial design: Exploring the efficacy and safety of two dose regimens of alpha1-proteinase inhibitor augmentation therapy in alpha1-antitrypsin deficiency
Respiratory Medicine2015-02-1343 citations
Pharmacokinetic comparability of Prolastin®-C to Prolastin® in alpha₁-antitrypsin deficiency: a randomized study.
2010-09-3010 citations