norUrsodeoxycholic Acid vs Placebo in PSC

Dr. Falk Pharma

Status and phase: Active, not recruiting; Phase 3

Conditions: Primary Sclerosing Cholangitis

Treatments: Drug: norUrsodeoxycholic Acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT03872921

NUC-5/PSC

Details and patient eligibility

About

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.

Enrollment: 303 patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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303 participants in 2 patient groups, including a placebo group

norUrsodeoxycholic acid

Experimental group

Description:

norUrsodeoxycholic acid 250mg capsules, 6 capsules/day for 2 years

Treatment:

Drug: norUrsodeoxycholic Acid

Placebo to norUrsodeoxycholic acid

Placebo Comparator group

Description:

norUrsodeoxycholic acid 250mg Placebo-capsules, 6 capsules/day for 2 years

Treatment:

Drug: norUrsodeoxycholic Acid