Clin2
NCT05005975Possibly a fitRecruiting

Safety study of oral dersimelagon for erythropoietic porphyria

EPPXLP

Part of Blood & lymphatic, Genetic & congenital, Skin clinical trials.

This trial checks the long-term safety and side effects of an oral medicine called dersimelagon in people with erythropoietic protoporphyria (EPP) or X-linked protoporphyria (XLP). It is mainly for people who have already finished an earlier dersimelagon study and are able to keep coming to clinic visits.

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

Phase
Phase 3
Enrollment
301 people
Ages
12 years to 75 years
Study type
Interventional

Who can take part

  • You must have already completed a prior dersimelagon study visit schedule (ending around Week 58 or later, per the study plan).
  • You must be able and willing to travel to the study sites for all scheduled visits.
  • You must sign consent (and for teens, get both teen agreement and parent permission).
  • If you can become pregnant: you must have a negative urine pregnancy test before the first dose and use 2 effective contraception methods during the study.
  • You must not have EPP/XLP caused by other skin conditions (no other photodermatoses besides EPP/XLP).
  • You must not have serious liver problems, and blood tests must be below certain limits (AST/ALT/ALP and bilirubin).

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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