Trial Details
Luspatercept-aamt
Active, not recruiting
Area of Research: Anemia Due to MDS
Phase 2

An Efficacy and Safety Study of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS) in Japanese Subjects Who Are Not Requiring Red Blood Cell Transfusion

Brief Summary:

The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.This is a Phase 2, multicenter, single-arm study to evaluate the efficacy, safety and Pharmacokinetics (PK) of luspatercept (ACE-536) for the treatment of anemia due to International prognostic scoring system-Revised (IPSS-R) very low, low or intermediate risk Myelodysplastic syndromes (MDS)in Japanese subjects who are not requiring Red blood cell (RBC) transfusion.The study is divided into the Screening Period, a Treatment Period and a Post-Treatment Follow up Period.

For more information, please contact the recruiting sites directly.
If there is no contact information, please email: Clinical.Trials@bms.com. The first line of the email MUST contain the NCT # and Site #.

24 locations available.
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