Trials / Active Not Recruiting
Active Not RecruitingNCT05567458
A Study to Evaluate Luspatercept (ACE-536) in Chinese Participants Who Require Regular Red Blood Cell Transfusions Due to Beta (β)-Thalassemia.
A Phase 2, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Luspatercept (ACE-536) in Chinese Adult Subjects Who Require Regular Red Blood Cell Transfusions Due to Beta (β)-Thalassemia
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 94 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of luspatercept plus best supportive care (BSC) versus placebo plus BSC in participants who require regular red blood cell transfusions due to β-thalassemia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Luspatercept | Specified dose on specified days |
| DRUG | Placebo | Specified dose on specified days |
Timeline
- Start date
- 2022-10-17
- Primary completion
- 2025-08-01
- Completion
- 2026-08-01
- First posted
- 2022-10-05
- Last updated
- 2025-08-12
Locations
10 sites across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05567458. Inclusion in this directory is not an endorsement.