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Clinical Trial 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


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02604433
Study type Interventional
Source Celgene
Contact
Status Completed
Phase Phase 3
Start date May 2, 2016
Completion date January 5, 2021

See also
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