norUrsodeoxycholic Acid vs Placebo in PSC

Phase 3Active Not RecruitingNCT03872921

Dr. Falk Pharma GmbH303 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

303

Conditions

Primary Sclerosing Cholangitis

Interventions

norUrsodeoxycholic AcidDRUG

oral treatment

Eligibility

Sex: ALLMin age: 16 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

Medical University of Vienna, Department of Internal Medicine III

Vienna, Austria

Medical School Hannover

Hanover, Lower Saxonia, Germany

Outcomes

Primary Outcomes

superiority of norursodeoxycholic acid (norUDCA) compared to placebo in the treatment of Primary Sclerosing Cholangitis (PSC)

prevention of disease progression assessed by partial normalization of serum Alkaline Phosphatase (s-ALP) levels in patients with PSC

Time frame: 2 years

Show superiority of norursodeoxycholic acid (norUDCA) compared to placebo in the treatment of Primary Sclerosing Cholangitis (PSC)

prevention of disease progression assessed by liver histology

Time frame: 2 years

Data from ClinicalTrials.gov

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