At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 75 enrolled
Drug / intervention
Luspaterceptdrug
Likely dose
Luspatercept 1.0 mg/kgfrom 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.
An Open-Label Extension Study to Evaluate the Long-Term Effects of ACE-536 for the Treatment of Anemia in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) Previously Enrolled in Study A536-03
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA·interventional·Posted Oct 20, 2014·Updated Jul 29, 2024
In Brief
A Phase 2 clinical trial evaluating Luspatercept for Myelodysplastic Syndromes. Completed, enrolled 75 participants across 1 site.
Detailed Summary
This study is an open-label extension study for participants previously enrolled in study MK-6143-001 (formerly called A536-03, ClinicalTrials.gov Identifier NCT01749514), to evaluate the long-term safety and tolerability of luspatercept (MK-6143) in participants with low or intermediate-1 risk MDS.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndromes
CountriesGermany
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartOct 2014
First PostedOct 2014
Primary CompletionMar 2020
TodayJul 2026
First PostedOct 20, 2014
Enrollment StartOct 9, 2014
Primary CompletionMar 19, 2020
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 11.7 years ago
Interventions
Luspaterceptdrug
Luspatercept 1.0 mg/kg once every 3 weeks by subcutaneous injection.