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A research study looking at long-term treatment with etavopivat in people with sickle cell disease

Hematology Oncology, Hematology
Zahra Pakbaz
An open-label, multi-centre, rollover study to characterise long-term safety and efficacy of etavopivat in adults, adolescents and children who have sickle cell disease or thalassaemia and have completed a treatment period in an etavopivat study
Blood - Hematologic
Sickle Cell Disease SCD

Study Description

Eligibility

  1. Participant must have ongoing participation in an etavopivat parent study for treatment of sickle cell disease (SCD) or thalassaemia and have completed at least a treatment period of the parent study.
  2. Participant must have derived clinical benefit from treatment with etavopivat, as determined by the investigator.
  3. Any participant with dose reduction or temporary discontinuation will need to be rechallenged before transferring.
  4. Participants on hydroxyurea (HU), crizanlizumab or l-glutamine oral powder (Endari®) treatment at the time of consent may be eligible if they:
  5. Have been on a stable dose during participation in the parent study (i.e., no changes to the dose except for changes to weight or age reasons).
  6. Have been compliant with the treatment regimen at the discretion of the investigator during participation of the parent study.
  1. Any disorder, except for conditions associated with SCD or thalassaemia, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
  2. Participant withdrew or had permanent treatment discontinuation from an etavopivat clinical study.
  3. Participants on permanent dose reduction or temporary treatment discontinuation.
  4. Use of any of the following within the timeframes prior to the transfer visit as stated:
  5. Use of voxelotor within participation of the parent study or anticipated need for this agent during this study.
  6. Use of an experimental selectin antagonist (e.g., monoclonal antibody or small molecule) within the parent study or anticipated need for such agents during this study.
  7. Use of erythropoietin or other haematopoietic growth factor treatment within the parent study or anticipated need for such agents during this study.
  8. Receiving or use of concomitant medications that are strong inducers of cytochrome P450 (CYP) 3A4 within 2 weeks of the transfer visit or anticipated need for such agents during the study.
  9. Current participation in a study that is not a designated parent study, or planned participation in any other clinical trial, for the duration of FLORAL.
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