Long-term Safety of Alpha1-Proteinase Inhibitor (Human) in Japanese

Status Completed

Clinical Trial Summary

This is a multi-center, open-label study to evaluate the long-term safety of weekly intravenous (IV) infusions of 60 mg/kg alpha1-PI (human), modified process (Alpha-1 MP) in adult participants with Alpha1 Antitrypsin Deficiency (AATD) in Japan who have completed Study GTI1401 (NCT02870309).

Clinical Trial Description

This is a multi-center, open-label study to evaluate the long-term safety of weekly IV infusions of 60 mg/kg Alpha-1 MP in adult participants with AATD in Japan who have completed Study GTI1401. Study GTI1401 is being conducted to evaluate the safety and pharmacokinetics (PK) of Alpha-1 MP in participants with AATD in Japan. In the current study, GTI1401-OLE, participants will be administered 60 mg/kg Alpha-1 MP by weekly IV infusion for approximately 1 year (can be renewed annually with the consent of the participants unless the sponsor informs of discontinuation of this OLE trial) to assess the long-term safety of Alpha-1 MP in participants with AATD. This study will be conducted at up to 5 centers in Japan. At the Week 9 Visit of Study GTI1401, after giving consent, on the same day, participants will be assessed for eligibility at Screening/Extension (Ext) Week 1 Visit for this extension study, Study GTI1401-OLE. If eligible, participants will be administered weekly IV infusions of 60 mg/kg Alpha-1 MP for approximately 1 year or longer. The Week 9 Visit of GTI1401 will be the End of Study Visit for the participants who are enrolled in Study GTI1401-OLE. Participants in Study GTI1401-OLE will have the option to remain in Study GTI1401-OLE and continue to receive weekly IV infusions of 60 mg/kg Alpha-1 MP for another year or longer. If participants plan to conclude their participation in the study (GTI1401-OLE) early (before Ext. Week 52), participants will be asked to complete the End of Study Follow-Up Assessments, which will be scheduled 4 weeks after the last infusion. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02870348
Study type	Interventional
Source	Grifols Therapeutics LLC
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	July 29, 2016
Completion date	February 16, 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02282527` - A Study to Assess Safety and PK of Liquid Alpha1-Proteinase Inhibitor (Human) in Treating Alpha1-Antitrypsin Deficiency	Phase 2/Phase 3
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	`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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Long-term Safety of Alpha1-Proteinase Inhibitor (Human) in Japanese Subjects With Alpha1 Antitrypsin Deficiency (GTI1401-OLE)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms