NCT01736683

Study of Sotatercept for the Treatment of Anemia in low-or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) or Non-proliferative Chronic Myelomonocytic Leukemia (CMML)

An Open-label, Randomized, Phase 2, Parallel, Dose-Ranging, Multicenter Study of Sotatercept for the Treatment of Patients With Anemia and Low or Intermediate-1 Risk Myelodysplastic Syndromes or Non-proliferative Chronic Myelomonocytic Leukemia (CMML)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine a safe, tolerable and effective dose of sotatercept that results in the greatest frequency of improvement of anemia in patients diagnosed with low- or intermediate-1 risk myelodysplastic syndromes (MDS) or non-proliferative chronic myelomonocytic leukemia (CMML).

Conditions

• Anemia
• Myelodysplastic Syndromes
• Chronic Myelomonocytic Leukemia
• Low to Intermediate-1 MDS
• Myelodysplastic Syndromes (MDS)
• Chronic Myelomonocytic Leukemia (CMML)

Interventions

Type	Name	Description
DRUG	Sotatercept	Sotatercept is supplied as a lyophilized powder that is reconstituted using Water for Injection (WFI) and administered as a subcutaneous injection (SC) injection by the study staff at the clinical site.

Timeline

• Start date: 2012-11-28
• Primary completion: 2018-04-30
• Completion: 2018-04-30
• First posted: 2012-11-29
• Last updated: 2022-10-24
• Results posted: 2019-06-13

Locations

20 sites across 2 countries: United States, France