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NCT05883748Possibly a fitEnrolling by invitation

Long-term study of bitopertin for EPP safety and benefit

Erythropoietic Protoporphyria

Part of Digestive system, Genetic & congenital, Hormones & metabolism, Skin clinical trials.

This trial studies how safe and well bitopertin works over the long term for people with EPP. It mainly includes people who already finished an earlier bitopertin study, to keep tracking side effects and overall progress.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2/Phase 3
Enrollment
230 people
Ages
12 years and older
Study type
Interventional

Who can take part

  • You have a confirmed EPP diagnosis and finished a prior bitopertin study phase (including the end-of-study visit)
  • You are at least 12 years old when you sign up
  • You meet the study’s body size limits (for under 18: at least 32 kg; for adults: BMI at least 18.5)
  • If you could become pregnant (or your partner could), you must use very reliable birth control during the study and for at least 30 days after the last dose
  • You can’t be pregnant (negative urine or blood pregnancy test if you could become pregnant)
  • You must be able to follow study visits and instructions and sign consent (assent if needed)

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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