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Pharmacokinetics, Pharmacodynamics and Safety of Epeleuton in Patients with Sickle Cell Disease

Studying Epeleuton effects and safety for sickle cell patients.

Recruiting
18 years and older
All
Phase 2

Study Overview: This study is about testing a drug called Epeleuton to see how it moves and works in the body and if it's safe for adults with sickle cell disease (SCD). Sickle cell disease is a condition where red blood cells, which carry oxygen, are sickle-shaped and can block blood flow. Participants must be 18 years or older. The study includes taking Epeleuton capsules for 16 weeks, with a 28-day period beforehand to prepare, and a 30-day follow-up after.

Participation: To be in the study, you should have SCD and have experienced 2 to 15 pain episodes in the last year. If you're on a medicine called hydroxyurea, your dose should not change soon. You'll need to agree to use birth control if you or your partner can have children. You cannot join if you have regular blood transfusions or have had a stem cell transplant.

  • Study lasts about 5 months in total.
  • Requires stable medication dose if currently on hydroxyurea.
  • Effective birth control is necessary if applicable.
Study details
    Sickle Cell Disease

NCT05861453

Afimmune

13 December 2024

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