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A Study to Evaluate Luspatercept (ACE-536) in Chinese Participants Who Require Regular Red Blood Cell Transfusions Due to Beta (β)-Thalassemia.
Sponsor: Bristol-Myers Squibb
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
94
Start Date
2022-10-17
Completion Date
2026-08-01
Last Updated
2025-08-12
Healthy Volunteers
No
Conditions
Interventions
Luspatercept
Specified dose on specified days
Placebo
Specified dose on specified days
Locations (10)
Local Institution - 0002
Maoming, Guangdong, China
Local Institution - 0005
Shenzhen, Guangdong, China
Local Institution - 0007
Liuchow, Guangxi, China
Local Institution - 0003
Nanning, GX, China
Local Institution - 0006
Haikou, Hainan, China
Local Institution - 0010
Kunming, Yunnan, China
Local Institution - 0009
Guangzhou, China
Local Institution - 0004
Guangzhou, China
Local Institution - 0008
Haikou, China
Local Institution - 0001
Nanning, China