RecruitingPhase 2NCT05664737

A Study to Determine the Efficacy and Safety of Luspatercept in Adult Participants and to Evaluate the Safety and Pharmacokinetics in and Adolescent Participants With Alpha (α)-Thalassemia

A Phase 2, Study for the Treatment of Anemia With Alpha (α)-Thalassemia to Determine the Efficacy and Safety of Luspatercept (BMS-986346/ACE-536) in Adults and Evaluate the Safety and Pharmacokinetics in Adolescents

Sponsor

Bristol-Myers Squibb

Enrollment

189 participants

Start Date

Dec 9, 2022

Study Type

INTERVENTIONAL

Conditions

Anemia

Summary

The purpose of the study is to evaluate the efficacy and safety of luspatercept plus best supportive care (BSC) vs placebo plus BSC on anemia in adult participants with α-thalassemia hemoglobin H (HbH) disease and determine the safety and drug levels in adolescent participants.

Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Luspatercept and a drug called Placebo for people with anemia. The study is currently recruiting participants at 36 locations. People eligible for this study include aged 12 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALLuspatercept

Specified dose on specified days

DRUGPlacebo

Specified dose on specified days

Locations(36)

Local Institution - 0008

Halifax, Nova Scotia, Canada

Sun Yat-sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, GD, China

Nanfang Hospital of Southern Medical University

Guangzhou, GD, China

The First People's Hospital of Foshan

Foshan, Guangdong, China

Maoming People's Hospital

Maoming Shi, Guangdong, China

Shenzhen Second People's Hospital

Shenzhen Shi, Guangdong, China

Liuzhou People's Hospital

Liuzhou, Guangxi, China

People's Liberation Army The 923rd Hospital

Nanning, GX, China

Local Institution - 0011

Haikou, Hainan, China

Local Institution - 0012

Kunming, Yunnan, China

Hainan General Hospital

Haikou, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, China

Local Institution - 0005

Thessaloniki, B, Greece

Local Institution - 0018

Rio, G, Greece

Local Institution - 0006

Athens, Greece

Local Institution - 0009

Goudi, Greece

Local Institution - 0007

Larissa, Greece

Local Institution - 0025

Hong Kong, HK, Hong Kong

Local Institution - 0024

Hong Kong Island, Hong Kong

Local Institution - 0022

Cagliari, CA, Italy

Local Institution - 0026

Genova, GE, Italy

Local Institution - 0020

Orbassano, TO, Italy

Local Institution - 0028

Naples, Italy

"Universita degli Studi della Campania ""Luigi Vanvitelli"" - AOU - Clinica Pediatrica"

Naples, Italy

Hospital Tunku Azizah

Kuala Lumpur, WP, Malaysia

Hospital Sultanah Aminah

Johor Bahru, Malaysia

Local Institution - 0035

Al-Ahsa, Saudi Arabia

King Saud University (KSU) - College of Medicine

Riyadh, Saudi Arabia

KK Women's and Children's Hospital

Singapore, Singapore

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, KHH, Taiwan

National Taiwan University Hospital

Nan Gang Qu, TPE, Taiwan

China Medical University Hospital

Taichung, TXG, Taiwan

Siriraj Hospital

Bangkok Noi, Bangkok, Thailand

Naresuan University Hospital

Mueang Phitsanulok, Thailand

Hacettepe Üniversitesi Tıp Fakültesi

Altındağ, Turkey (Türkiye)

Istanbul Universitesi - Istanbul Tip Fakultesi (ITF) Hastanesi

Topkapı, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

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NCT05664737

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