Clinical trial
A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus…
NCT03682536 · Celgene, Industry · Active, not recruiting
Key facts
| NCT number | NCT03682536 |
|---|---|
| Title | A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve |
| Official title | A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alpha for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Due to Myelodysplastic Syndrome (MDS) in ESA Naïve Subjects Who Require Red Blood Cell Transfusions |
| Acronym | COMMANDS |
| Lead sponsor | Celgene, Industry |
| Collaborators | Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA Industry |
| Status | Active, not recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Myelodysplastic Syndromes |
| Intervention type | Drug |
| Interventions | Luspatercept, Epoetin alfa |
| Enrollment | 363 |
| Start date | Jan 2, 2019 |
| Primary completion | Mar 31, 2023 |
| Completion | Sep 28, 2027 |
| First posted | Sep 24, 2018 |
| Last update posted | Nov 20, 2024 |
| Countries | Australia, Austria, Belgium, Canada, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Japan and 14 more |
At a glance
- 100–999 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: