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NCT02631070 · ClinicalTrials.gov registry record · Phase 3
A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes
A Phase 3 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 3
- Development phase
- 229
- Enrollment target
NCT02631070 is a Phase 3 study that has completed, run by Celgene. The registered enrollment target is 229 participants.
The verdict
NCT02631070, a Phase 3 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 229 participants
- Enrollment target
Study Summary
The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) versus placebo in participants with anemia due to the Revised International Prognostic Scoring System (IPSS-R) very low, low, or intermediate MDS with ring sideroblasts who require red blood cell (RBC) transfusions.
Interventions
- OTHER Placebo
- DRUG Luspatercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 229 participants |
| Start Date | 2016-02-09 |
| Est. Completion | 2020-11-26 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02631070
The ClinicalTrials.gov registry entry for NCT02631070 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 229 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02631070 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02631070 about?
NCT02631070 is a clinical study titled "A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes". The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This is a Phase 3, double-blind, randomized, placebo-contr...
What is the current status of trial NCT02631070?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 229 participants. The study started on 2016-02-09. Estimated completion is 2020-11-26.
What interventions are being tested in trial NCT02631070?
The interventions under investigation include: Placebo (OTHER), Luspatercept (DRUG).
Who is sponsoring clinical trial NCT02631070?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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