Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT02604433
Brief 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
Study:
NCT02604433
Study Brief:
Protocol Section:
NCT02604433