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Clinical Trial Summary

Grifols Therapeutics Inc. is conducting a multi-center, randomized, double-blind, crossover study to evaluate the safety, immunogenicity, and pharmacokinetics (PK) of Liquid Alpha1-PI compared to the currently licensed product, Prolastin-C, in subjects with Alpha1-Antitrypsin Deficiency (AATD).


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02282527
Study type Interventional
Source Grifols Therapeutics Inc.
Contact
Status Completed
Phase Phase 2/Phase 3
Start date October 2014
Completion date January 2016

See also
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Completed NCT01651351 - GLASSIA Infusion Rate Study Phase 4
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Completed NCT02870348 - Long-term Safety of Alpha1-Proteinase Inhibitor (Human) in Japanese Subjects With Alpha1 Antitrypsin Deficiency (GTI1401-OLE) Phase 1/Phase 2
Completed NCT04474197 - Evaluation of the Efficacy and Safety of VX-864 in Subjects With the PiZZ Genotype Phase 2
Completed NCT00161707 - Safety Study of an Aerosolized, Recombinant Alpha 1-Antitrypsin in Subjects With Alpha 1-Antitrypsin Deficiency Phase 1/Phase 2
Withdrawn NCT05466747 - A Study of RYMPHYSIA for Alpha1-Proteinase Inhibitor (A1PI) Therapy in Adults With A1PI Deficiency and Chronic Obstructive Pulmonary Disease (COPD)-Emphysema Phase 4
Enrolling by invitation NCT05899673 - An Extension Study to Learn About the Long-Term Safety of Fazirsiran and if Fazirsiran Can Help People With Alpha-1 Antitrypsin Liver Disease Phase 3
Recruiting NCT04722887 - A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Two Different Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Participants With Alpha1-Antitrypsin Deficiency Phase 1/Phase 2
Recruiting NCT02929940 - Liver Disease in Patients With alpha1-antitrypsin Deficiency N/A