An open, non-randomized, parallel-group pharmokinetic and -dynamic, investigator-initiated study on effects of obeticholic acid (OCA) in bile of patients with primary biliary cholangitis (PBC) and non-alcoholic steatohepatitis (NASH) in comparison to healthy controls

An open, non-randomized, parallel-group pharmokinetic and -dynamic, investigator-initiated study on effects of obeticholic acid (OCA) in bile of patients with primary biliary cholangitis (PBC) and non-alcoholic steatohepatitis (NASH) in comparison to healthy controls - OCABILE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47216

Enrollment

Registered

2018-12-10

Start date

2017-07-13

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fatty liver disease non-alcoholic steatohepatitis Primary biliary cholangitis small bile duct injury

Interventions

Obeticholic acid 10mg once daily

Bile

NASH

Obeticholic acid

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Assess the effect of obeticholic acid (OCA) in patients with PBC [in combination with long-term UDCA treatment (15 mg/kg/d)], patients with NASH and healthy volunteers on the bile acid and lipid composition of bile and serum,	—

Secondary

Measure	Time frame
Assess the effect of obeticholic acid (OCA) in patients with PBC [in combination with long-term UDCA treatment (15 mg/kg/d)], patients with NASH and healthy volunteers on the biliary and serum levels of cytokines (e.g., IL-6, IL-8, TNF*), chemokines and enterohepatic hormones (e.g., FGF-19) Assess the effect of obeticholic acid (OCA) in patients with PBC [in combination with long-term UDCA treatment (15 mg/kg/d)], patients with NASH and healthy volunteers on the bile acid composition and microbiome in faeces Assess the effect of obeticholic acid (OCA) in patients with PBC [in combination with long-term UDCA treatment (15 mg/kg/d)], patients with NASH and healthy volunteers on the expression of duodenal transport proteins and enzymes contributing to the biliary and intestinal detoxification machinery	—

Measure

Time frame

Assess the effect of obeticholic acid (OCA) in patients with PBC [in combination with long-term UDCA treatment (15 mg/kg/d)], patients with NASH and healthy volunteers on the biliary and serum levels of cytokines (e.g., IL-6, IL-8, TNF*), chemokines and enterohepatic hormones (e.g., FGF-19) Assess the effect of obeticholic acid (OCA) in patients with PBC [in combination with long-term UDCA treatment (15 mg/kg/d)], patients with NASH and healthy volunteers on the bile acid composition and microbiome in faeces Assess the effect of obeticholic acid (OCA) in patients with PBC [in combination with long-term UDCA treatment (15 mg/kg/d)], patients with NASH and healthy volunteers on the expression of duodenal transport proteins and enzymes contributing to the biliary and intestinal detoxification machinery

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)