norUrsodeoxycholic Acid vs Placebo in PSC

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Double-blind, randomized, multi-center, placebo-controlled, comparative, phase III trial. The study will be conducted with two treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with either 1500 mg/d norursodeoxycholic acid capsules or placebo capsules for the treatment of Primary Sclerosing Cholangitis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Falk Pharma GmbH

Criteria

Inclusion Criteria:

• Signed informed consent

• verified PSC

• Liver Biopsy available for Review

• If pre-treated with UDCA Patient must be on stable dose not exceeding 20mg/kg/bw

• Patients with or without concomittant IBD

Exclusion Criteria:

• History or presence of other concomitant liver diseases

• Presence of Cholangiocarcinoma

• Secondary causes of Sclerosing Cholangitis

• Small Duct Cholangitis in the absence of large duct disease

• Any known relevant infectious disease

• Abnormal renal function

• Any active malignant disease

• Known intolerance/hypersensitivity to study drug