Study with Norucholic Acid Tablets in Patients with Primary Sclerosing Cholangitis (PSC)

Phase 3Not Yet RecruitingNCT06886360

Dr. Falk Pharma GmbH120 enrolled

Overview

Open-label, multi-center, phase III trial. Oral treatment with 1500 mg norucholic acid in Primary Sclerosing cholangitis

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Primary Sclerosing Cholangitis

Interventions

norucholic acidDRUG

500 mg norucholic acid film-coated tablets; 3 tablets/day

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Signed informed consent. 2. Males or females ≥ 18 years. 3. Patient has previously been diagnosed with PSC, has participated in the previous NUC 5/PSC trial and has completed the DBE phase with Visit 22, or has prematurely terminated the DBE phase before this trial has been started, or has prematurely terminated the DBE phase after this trial has been started, under the condition that the premature termination was due to lack of efficacy\*. (\*Lack of efficacy as defined in the NUC-5/PSC trial.) Exclusion Criteria: 1. History or presence of chronic alcoholic consumption (daily consumption \> 30 g in men, \> 20 g in women). 2. Patients who discontinued study participation in NUC-5/PSC due to an AE possibly caused by the study drug. 3. Liver Cirrhosis or any cirrhosis-related symptoms which in the opinion of the investigator may affect the patient's safety. 4. History of liver transplantation or patient listed for transplantation.