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This study will open for enrollment soon. Please contact the study team for more information and check back frequently.

Hibiscus2 (Sickle Cell Disease) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called etavopivat (the study drug) is a safe and effective option for children and adolescents who have SCD.

What is the Condition Being Studied?

Sickle Cell Disease (SCD)

Who Can Participate in the Study?

Children ages 12-17 who:

  • Are diagnosed with SCD
  • Have had at least 15 documented vaso-occlusive crises (pain crises)

For more information, contact the study team at morgan.low@duke.edu.

Age Group
Adults, Children

What is Involved?

If you and your child choose to take part in this study, they will get a random assignment (like a coin flip) to either:

  • Take a 400mg dose of the study drug; OR
  • Take a placebo (inactive substance with no drug in it)

Your child will take the study drug or placebo for 1 year. After this year is finished, you and they will have the option to continue on to Part 2 of the study. In Part 2, everyone will receive a 400mg dose of the study drug regardless of whether or not they took the study drug or placebo for the first year. Part 2 will also last for 1 year.

Study Details

Full Title
A global phase 3, randomised, double-blind and placebo-controlled study evaluating the efficacy and safety of etavopivat in adolescents and adults with sickle cell disease
Principal Investigator
Pediatric Hematology-Oncology Specialist
Protocol Number
IRB: PRO00116729
NCT: NCT06612268
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon