A study on the effect of obetihcolic acid on bile composition in patients with PBC (chronic liver disease of the small bile ducts), NASH (chronic liver disease as a result of fatty liver) and healthy volunteers

Phase 1

Active, not recruiting

• Conditions: Primary biliairy cholangitis (PBC)Non-alcoholic steatohepatitis (NASH); MedDRA version: 20.0Level: SOCClassification code 10019805Term: Hepatobiliary disordersSystem Organ Class: 10019805 - Hepatobiliary disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-002965-67-NL
• Lead Sponsor: AMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-29
• Last Update Posted: 17 July 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Male or female patients / volunteers of 18 to 75 years of age.
-Body mass index within 18 to 40 kg/m2
-Positive AMA (anti-mitochondrial antibody) testing (for PBC patients).
-Proven non-cirrhotic liver disease compatible with PBC stage I, II, III or NASH, no reliable signs of portal hypertension such as esophageal varices or ascites and/or pylephlebectasia > 15 mm, and a fibroscan < 15 kPa.
-The diagnosis of NASH must be confirmed by a liver biopsy (e.g. according Brunt criteria) in the last 24 months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 33
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Existing cardiac / hematological / renal / gastrointestinal diseases which might interfere with the drugs' safety, tolerability, absorption, pharmacokinetics and / or endoscopy.
-Other acute or chronic diseases which might affect absorption or metabolism of OCA
-Existing disorders of the coagulation system or treatment with anticoagulants or agents inhibiting thrombocyte aggregation
-Positive anti-HIV-test, HBsAg-test or anti-HCV-test.
-Acute inflammation of the gallbladder.
-Cholecystectomy
-Histologically proven cirrhotic liver disease or total bilirubin > 2 mg/dl or reliable signs of portal hypertension such as esophageal varices or ascites and/or pylephlebectasia > 15 mm and / or fibroscan > 15 kPa.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified