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An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Adults Who Require Regular Red Blood Cell Transfusions Due to Beta (β) Thalassemia
NCT02604433 · View on ClinicalTrials.gov ↗
Study Summary
This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) plus Best supportive care (BSC) versus placebo plus BSC in adults who require regular red blood cell transfusion due to (β)-thalassemia. The study is divided into the following periods: * Historical Period, * Screening/Run-in Period, * Double-blind Treatment Period (48 weeks), * Double-blind Long-term Treatment Period, (at the investigator's discretion an additional 48 weeks), * Open-Label Phase post unblinding and upon Data Monitoring Committee positive recommendation * Post-treatment Follow-up Period
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Luspatercept
Study Locations (20)
Other
- Royal Prince Alfred Hospital — Camperdown
- University Mulitiprofile Hospital for Active Treatment Sveti Georgi EAD — Plovdiv
- Specialized Hospital for Active Treatment of Haematological Diseases - Sofia — Sofia
- Multiprofile Hospital for Active Treatment Sveta Marina EAD — Varna
- Hopital Henri Mondor — Créteil
- GH de Institut Catholique St. VincentHématologie — Lille
- Hopitaux de La Timone — Marseille
- Hospital of Necker — Paris
California
- Children's Hospital of Los Angeles — Los Angeles
- Children's Hospital and Research Center at Oakland — Oakland
Illinois
- Ann and Robert H Lurie Childrens Hospital of Chicago — Chicago
Massachusetts
- Boston Children's Hospital — Boston
New York
- Weill Cornell Medical College — New York
Pennsylvania
- Hospital of the University of Pennsylvania — Philadelphia
New South Wales
- Prince of Wales Hospital — Randwick
Queensland
- Mater Hospital Brisbane — South Brisbane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 336 participants |
| Start Date | 2016-05-02 |
| Est. Completion | 2021-01-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02604433
The ClinicalTrials.gov registry entry for NCT02604433 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 336 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 73 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Beta-Thalassemia appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02604433 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02604433 about?
NCT02604433 is a clinical study titled "An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Adults Who Require Regular Red Blood Cell Transfusions Due to Beta (β) Thalassemia". This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) plus Best supportive care (BSC) versus placebo plus BSC in adults who require regular red blood cell transfusion due to (β)-thalassemia. The study is div...
What is the current status of trial NCT02604433?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 336 participants. The study started on 2016-05-02. Estimated completion is 2021-01-05.
What conditions does trial NCT02604433 study?
This clinical trial studies the following conditions: Beta-Thalassemia, Erythrocyte Transfusion. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02604433?
The interventions under investigation include: Placebo (OTHER), Luspatercept (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02604433?
This trial is sponsored by Celgene, which has 73 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02604433 being conducted?
This trial has 20 study locations across California, Illinois, Massachusetts, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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