Clinical Trial

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

Withdrawn Phase 1
View on ClinicalTrials.gov →
Why the trial stopped
department leadership decided not to proceed with study
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-08-07; most recent amendment 2026-01-26.
Status change: Not Yet Recruiting → Withdrawn 2026-01-26
Trial Details
NCT Number NCT07123363
Lead Sponsor Wake Forest University Health Sciences
Conditions Protoporphyria
Start Date 2026-01
Primary Completion 2035-12 (estimated)
Study Completion 2035-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-29