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Clinical Trials in China / NCT05567458
Active, not recruiting Phase 2

A Study to Evaluate Luspatercept (ACE-536) in Chinese Participants Who Require Regular Red Blood Cell Transfusions Due to Beta (β)-Thalassemia.

NCT05567458 · tracked via the Priya Life Science China tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 2
Started
2022-10-17
Last updated
2025-08-12

Condition(s) studied

Beta-thalassemia

Investigational drug(s) / intervention(s)

LuspaterceptPlacebo

Luspatercept: Specified dose on specified days

Placebo: Specified dose on specified days

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Participant is willing and able to adhere to the study visit schedule (for example, not scheduled to receive hematopoietic stem cell transplantation \[HSCT\]) and other protocol requirements. * Participant has documented diagnosis of β-thalassemia or Hemoglobin E/β-thalassemia (β-thalassemia with mutation and/or multiplication of alpha (α) globin is allowed). * Participant is regularly transfused, defined as: 6-25 RBC units in the 24 weeks prior to randomization and no transfusion-free period for \>42 days during that period. * Participant has Eastern Cooperative Oncology Group (ECOG) score of 0 or 1. Exclusion Criteria: * Participant has a diagnosis of Hemoglobin S/β-thalassemia or α-thalassemia (for example, Hemoglobin H). * Participant has active hepatitis C virus (HCV) infection as demonstrated by a positive HCVribonucleic acid (RNA) test of sufficient sensitivity, or active infectious hepatitis B virus (HBV) as demonstrated by the presence of hepatitis B surface antigen (HBsAg) and/or HBVdeoxyribonucleic acid (DNA) positive, or known positive human immunodeficiency virus (HIV). * Participant has a history of deep venous thrombosis or stroke or thromboembolic events (venous or arterial) requiring medical intervention ≤24 weeks prior to randomization. * Participant uses chronic anticoagulant therapy, unless the treatment stopped at least 28 days prior to randomization. Anticoagulant therapies used for prophylaxis for surgery or high-risk procedures as well as low-molecular-weight heparin for superficial venous thrombosis and chronic aspirin are allowed. * Participant who has EMH complications requiring treatment to control the growth of EMH mass(es) during the screening period. * Participant used immunomodulatory imide drugs (IMiDs) ≤ 24 weeks prior to randomization

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
Local Institution - 0002 Maoming Guangdong
Local Institution - 0005 Shenzhen Guangdong
Local Institution - 0007 Liuzhou Guangxi
Local Institution - 0003 Nanning GX
Local Institution - 0006 Haikou Hainan
Local Institution - 0010 Kunming Yunnan
Local Institution - 0009 Guangzhou China
Local Institution - 0004 Guangzhou China
Local Institution - 0008 Haikou China
Local Institution - 0001 Nanning China

More Bristol-Myers Squibb trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05567458 on ClinicalTrials.gov ↗ ← All trials in China