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NCT02604433 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Beta-Thalassemia and Erythrocyte Transfusion, sponsored by Celgene.
- Completed
- Registry status
- Phase 3
- Development phase
- 336
- Enrollment target
- 20
- Study locations
NCT02604433: Completed Phase 3 study of Beta-Thalassemia and Erythrocyte Transfusion, sponsored by Celgene.
NCT02604433 is a Phase 3 study of Beta-Thalassemia and Erythrocyte Transfusion that has completed, run by Celgene. The registered enrollment target is 336 participants, above the 157-participant average among 14 other Beta-Thalassemia trials with a reported enrollment target (114% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02604433, a Phase 3 study of Beta-Thalassemia and Erythrocyte Transfusion, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 336 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
Erythroid Response was defined as red blood cell (RBC) transfusion burden reduction from baseline ≥ 33% with a reduction of at least 2 units during Week 13 - 24 compared to the 12-week interval on or prior to Dose 1 Day 1.
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 |
What the finished NCT02604433 record still lists
NCT02604433 is an interventional study that assigns participants to a tested intervention. The registered 336 participants enrollment target is mid-sized for trials with a published cap, above the 157-participant average among 14 other Beta-Thalassemia trials with a reported enrollment target (114% higher).
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.
NCT02604433 names 20 study sites across 12 states, led by Other, California, Illinois.
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.
What interventions are being tested in trial NCT02604433?
The interventions under investigation include: Placebo (OTHER), Luspatercept (DRUG).
Who is sponsoring clinical trial NCT02604433?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT02604433's enrollment target sits among peer trials
336 3rd of 14 higher than 12 of 14 other Beta-Thalassemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Beta-Thalassemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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