Clinical Trials Logo

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
  Status Clinical Trial Phase
Terminated NCT02722304 - Stage 1 Study of ARALAST NP and GLASSIA in A1PI Deficiency Phase 3
Withdrawn NCT04440488 - ARALAST NP Alpha-1 Lung Density Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E) Study Phase 4
Completed NCT02525861 - GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study Phase 3
Recruiting NCT05677971 - Study to Check the Safety of Fazirsiran and Learn if Fazirsiran Can Help People With Liver Disease and Scarring (Fibrosis) Due to an Abnormal Version of Alpha-1 Antitrypsin Protein Phase 3
Recruiting NCT06165341 - Study to Learn About the Safety of Fazirsiran and if it Can Help People With Alpha-1 Antitrypsin Liver Disease With Mild Liver Scarring (Fibrosis) Phase 3
Completed NCT00157092 - Study of the Effect of Aerosolized, Recombinant Alpha 1-Antitrypsin on Epithelial Lining Fluid Analytes in Subjects With Alpha 1-Antitrypsin Deficiency Phase 1/Phase 2
Terminated NCT00313144 - Aralast alpha1-proteinase Inhibitor Surveillance Study Phase 4
Completed NCT01651351 - GLASSIA Infusion Rate Study Phase 4
Completed NCT02870348 - Long-term Safety of Alpha1-Proteinase Inhibitor (Human) in Japanese Subjects With Alpha1 Antitrypsin Deficiency (GTI1401-OLE) Phase 1/Phase 2
Completed NCT02870309 - Safety and Pharmacokinetics of Alpha-1 MP (Alpha1-proteinase Inhibitor (Human), Modified Process) in Participants With Alpha1-Antitrypsin Deficiency 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