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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
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
Conditions
Interventions
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