CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 74 enrolled
Drug / intervention
Sotaterceptdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01736683
NCT01736683Phase 2Completed
CompareCT.gov

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)

Merck Sharp & Dohme LLC·interventional·Posted Nov 29, 2012·Updated Oct 24, 2022

In Brief

A Phase 2 clinical trial evaluating Sotatercept for Anemia and 5 related conditions. Completed, enrolled 74 participants across 20 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Low to Intermediate-1 MDS, Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML)
CountriesFrance, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 29, 2012
Enrollment StartNov 28, 2012
Primary CompletionApr 30, 2018
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 13.6 years ago

Interventions

Sotaterceptdrug

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.