At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 136 enrolled
Drug / intervention
Alpha-1 antitrypsin (AAT) +1 morebiological
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 Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III Trial of Alpha 1 - Antitrypsin (AAT) Combined With Corticosteroids vs Corticosteroids Alone for the Treatment of High Risk Acute Graft-versus-Host Disease (GVHD) Following Allogeneic Hematopoietic Stem Cell Transplant
In Brief
A Phase 3 clinical trial evaluating Alpha-1 antitrypsin (AAT) and Placebo for Graft Versus Host Disease (GVHD). Completed, enrolled 136 participants across 25 sites.
Detailed Summary
Study CSL964\_5001 will investigate the efficacy of AAT with corticosteroids compared with corticosteroids alone as first line therapy for patients with high-risk acute GVHD
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGraft Versus Host Disease (GVHD)
CountriesUnited States
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedNov 2019
Enrollment StartJan 2020
Primary CompletionSep 2023
Study CompletionJun 2024
TodayJul 2026
First PostedNov 19, 2019
Enrollment StartJan 9, 2020
Primary CompletionSep 11, 2023
Study CompletionJun 26, 2024
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 6.6 years ago
Interventions
Alpha-1 antitrypsin (AAT)biological
AAT is a lyophilized product for intravenous administration
Placebodrug
Albumin solution administered intravenously