Long-term Safety of Alpha1-Proteinase Inhibitor (Human) in Japanese Subjects With Alpha1 Antitrypsin Deficiency (GTI1401-OLE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02870348|
Recruitment Status : Enrolling by invitation
First Posted : August 17, 2016
Last Update Posted : May 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Alpha1-Antitrypsin Deficiency||Biological: Alpha-1 MP||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Alpha1 Antitrypsin Deficiency|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||March 15, 2020|
|Estimated Study Completion Date :||March 15, 2020|
Experimental: Alpha-1 MP
Alpha-1 MP 60 mg/kg administered weekly via intravenous administration
Biological: Alpha-1 MP
Weekly intravenous infusions of 60 mg/kg Alpha-1 MP
Other Name: Prolastin-C
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02870348
|Hiroskai University Hospital|
|Aomori, Japan, 036-8563|
|Hokkaido University Hospital|
|Hokkaido, Japan, 060-8648|
|Juntendo University Hospital|
|Tokyo, Japan, 113-8431|