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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: A Multi-Center, Open-Label Study to Evaluate the Long-term Safety of Weekly Intravenous Infusions of Alpha1-Proteinase Inhibitor (Human) in Japanese Subjects With

Brief Summary: 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 subjects with AATD in Japan who have completed Study GTI1401.

Detailed Summary:

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 subjects with AATD in Japan who have completed Study GTI1401. Study GTI1401 is being conducted to evaluate the safety and PK of Alpha-1 MP in subjects with AATD in Japan. In the current study, GTI1401-OLE, subjects 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 subjects unless the sponsor informs of discontinuation of this OLE trial) to assess the long-term safety of Alpha-1 MP in subjects 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, subjects will be assessed for eligibility at Screening/Extention (Ext) Week 1 Visit for this extension study, Study GTI1401-OLE. If eligible, subjects 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 subjects who are enrolled in Study GTI1401-OLE.

Subjects 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 subjects plan to conclude their participation in the study (GTI1401-OLE) early (before Ext. Week 52), they will be asked to complete the End of Study Follow-Up Assessments, which will be scheduled 4 weeks after the last infusion.


Sponsor: Grifols Therapeutics Inc.

Current Primary Outcome: Safety of 60 mg/kg Alpha-1 MP as assessed by Adverse events, ADRs, serious AEs (SAEs), discontinuations due to AEs or SAEs, and COPD exacerbations [ Time Frame: Week 1 to Week 56 ]

Adverse events, ADRs, serious AEs (SAEs), discontinuations due to AEs or SAEs, and COPD exacerbations


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Grifols Therapeutics Inc.

Dates:
Date Received: August 12, 2016
Date Started: November 2016
Date Completion: March 2018
Last Updated: December 1, 2016
Last Verified: December 2016