At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 4 enrolled
Drug / intervention
Alpha-1 MPbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Alpha-1 MP for Alpha1-Antitrypsin Deficiency. Completed, enrolled 4 participants across 3 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlpha1-Antitrypsin Deficiency
CountriesJapan
CollaboratorsGrifols Japan K.K.
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartJul 2016
First PostedAug 2016
Primary CompletionFeb 2021
TodayJul 2026
First PostedAug 17, 2016
Enrollment StartJul 29, 2016
Primary CompletionFeb 16, 2021
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 9.9 years ago
Interventions
Alpha-1 MPbiological
Alpha-1 MP is a stable, sterile, lyophilized preparation of human alpha1-PI, also known as alpha1-antitrypsin.