A study to evaluate the benefit and safety of Luspatercept (ACE-536) in adults with Beta-Thalassemia who require regular red blood cell tranfusions

Update Il y a 4 ans
Reference: EUCTR2015-003224-31

Woman and Man

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Extract

The primary objective of the study is: - To determine the proportion of subjects treated with luspatercept plus BSC versus placebo plus BSC who achieved erythroid response, defined as ≥ 33% reduction from baseline in transfusion burden (units RBCs / time) with a reduction of at least 2 units, from Week 13 to Week 24.


Inclusion criteria

  • Adults who require regular Red Blood Cell (RBC) transfusions due to Beta-Thalassemia