Trials / Active Not Recruiting
Active Not RecruitingNCT03805789
The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft-versus-host Disease (GVHD) in Patients Receiving Hematopoietic Cell Transplant
A Phase 2/3, Multicenter, randOmized, Double-blind, Placebo-controlled, stUdy to evaLuate the Safety and Efficacy of Alpha-1 AntiTrypsin for the prEvention of Graft-versus-host Disease in Patients Receiving Hematopoietic Cell Transplant (MODULAATE Study)
- Status
- Active Not Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 222 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This study is a phase 2 / 3 prospective, double-blind, randomized, multicenter, placebo-controlled study for prevention of acute GVHD (aGVHD) in participants undergoing an unrelated (matched or single allele mismatched) or matched related allogeneic hematopoietic cell transplantation (HCT).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AAT | AAT is a lyophilized product for IV administration. |
| BIOLOGICAL | Placebo | Albumin solution administered intravenously |
Timeline
- Start date
- 2019-03-27
- Primary completion
- 2026-03-31
- Completion
- 2026-03-31
- First posted
- 2019-01-16
- Last updated
- 2025-11-04
Locations
34 sites across 8 countries: United States, Australia, Germany, Italy, Japan, South Korea, Spain, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03805789. Inclusion in this directory is not an endorsement.