drugset / Trial / NCT07123363

Effect of Bitopertin on the Liver and on Levels of Protoporphyrin IX in Bile, Blood, Liver, and Stool in Patients With Erythropoietic Protoporphyria/X-linked Protoporphyria and Increased Liver Stiffness and/or Liver Enzymes at Baseline

NCT07123363

NaSingle-groupOpen-labelTreatment

Summary

The primary goal of this study is to assess safety and tolerability of bitopertin in subjects with Erythropoietic Protoporphyria (EPP) or X-linked Protoporphyria (XLP) and evidence of compensated liver disease.

Timeline

Start
2026-01
Primary completion
2035-12
Completion
2035-12

Drugs

EvaluationDrugModalityDoseRoute
Subject bitopertin Small molecule 60 mg Oral