norUrsodeoxycholic Acid vs Placebo in PSC

Double-blind, Randomized, Placebo-controlled, Phase III Study Comparing norUrsodeoxycholic Acid Capsules With Placebo in the Treatment of Primary Sclerosing Cholangitis

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.

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