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COMPLETED
NCT04477850
PHASE2

A Study to Evaluate the Efficacy, Drug Levels and Safety of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in Chinese and Japanese Participants With Ring Sideroblasts Who Require Red Blood Cell Transfusions

Sponsor: Celgene

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of luspatercept (ACE-536) for the treatment of anemia due to Revised International Prognostic Scoring System (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) in Chinese and Japanese participants with ring sideroblasts who require Red Blood Cells (RBC) transfusions.

Official title: A Phase 2, Multicenter, Single-Arm Bridging Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes(MDS) in Chinese and Japanese Subjects With Ring Sideroblasts Who Require Red Blood Cell Transfusions

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2020-11-30

Completion Date

2026-04-08

Last Updated

2026-05-05

Healthy Volunteers

No

Interventions

DRUG

Luspatercept

Specified dose on specified days

Locations (25)

Local Institution - 100

Beijing, China

Local Institution - 107

Chengdu, Sichuan, China

Local Institution - 105

Guangzhou, China

Local Institution - 103

Guangzhou, China

Local Institution - 109

Guangzhou, China

Local Institution - 102

Hangzhou, China

Local Institution - 112

Nanchang, China

Local Institution - 108

Nanjing, China

Local Institution - 114

Shanghai, China

Local Institution - 101

Shanghai, China

Local Institution - 104

Suzhu, China

Local Institution - 106

Tianjin, China

Local Institution - 111

Wenzhou, China

Local Institution - 110

Wuhan, China

Local Institution - 209

Matsuyama, Ehime, Japan

Local Institution - 203

Nagasaki, Nagasaki, Japan

Local Institution - 210

Sayama, Osaka, Japan

Local Institution - UNK11

Fukuoka, Japan

Local Institution - 206

Kamogawa, Japan

Local Institution - 201

Mibu-Machi, Japan

Local Institution - 205

Osaka, Japan

Local Institution - 208

Ōgaki, Japan

Local Institution - 204

Sagamihara, Japan

Local Institution - 207

Sendai, Japan

Local Institution - 202

Shinagawa-ku, Tokyo, Japan