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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

Alpha1-Antitrypsin Deficiency Clinical Trial

Official title:
A Multi-Center, Single-Dose and Repeat-Dose Over Eight Weeks, Sequential Cohort Study to Evaluate Safety and Tolerability as Well as Pharmacokinetics of Two Different Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% Administered Subcutaneously in Subjects With Alpha1-Antitrypsin Deficiency

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of 72 milligrams per kilogram (mg/kg) and 180 mg/kg Alpha-1 15%, administered as a single-dose subcutaneous (SC) infusion and subsequently as weekly SC infusions over 8 weeks in participants with Alpha1-Antitrypsin Deficiency (AATD).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04722887
Study type Interventional
Source Grifols Therapeutics LLC
Contact Beatriz Garcia Castro
Phone +(34) 670923669
Email beatriz.garcia@grifols.com
Status Recruiting
Phase Phase 1/Phase 2
Start date August 13, 2021
Completion date March 14, 2025
View Details
See also
  Status Clinical Trial Phase
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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Withdrawn NCT04440488 - ARALAST NP Alpha-1 Lung Density Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E) Study Phase 4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 NCT02929940 - Liver Disease in Patients With alpha1-antitrypsin Deficiency N/A