Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC).

A Phase 2, Double-Blind, Randomized, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid, Administered Alone or in Combination with Bezafibrate, in Subjects with Primary Biliary Cholangitis who had an Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002575-17-FR

Enrollment

Registered

2019-07-09

Start date

2019-10-14

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Primary Biliary Cholangitis (PBC) in patients with Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid MedDRA version: 20.1 Level: LLT Classification code 10036680 Term: Primary biliary cirrhosis System Organ Class: 100000004871

Interventions

Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA Pharmaceutical Form: Tablet INN or Proposed INN: obeticholic acid CAS Number: 459789-99-2 Current Sponsor code: 6-ECD

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - A definite or probable diagnosis of PBC (consistent with the European Association for the Study of the Liver [EASL] Practice Guidelines and the American Association for the Study of Liver Diseases; [Lindor 2009a, EASL 2017]) - Qualifying ALP and bilirubin liver biochemistry values - Age =18 years - Taking UDCA for at least 12 months (stable dose for =3 months) before Day 1 or unable to tolerate or unresponsive to UDCA (no UDCA for =3 months) before Day 1 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4

Exclusion criteria

Exclusion criteria: - History or presence of other concomitant liver diseases - Presence of clinical complications of PBC or clinically significant (CS) hepatic decompensation - Current or history of gallbladder disease with or without cholelithiasis - Severe renal failure (serum creatinine >1.5 mg/100 mL (>135 µmol/L); creatinine clearance <60 mL/min) or undergoing dialysis - Severe pruritus, or required systemic treatment for pruritus (eg, with bile acid sequestrants or rifampicin) within 2 months of Day 1 - History of known or suspected CS hypersensitivity to OCA, BZF, or other fibrates or any of their components - Was treated with commercially available OCA or participated in a previous study involving OCA within 1 year before Screening or plans to use commercially available OCA during the study - Is unable to tolerate BZF or other fibrates, was treated with commercially available fibrates or participated in a previous study involving fibrates within 3 months before Screening, or plans to use commercially available fibrates during the study Note: Other protocol defined Inclusion/Exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to assess the effects of the combination of OCA and BZF on alkaline phosphatase (ALP) in comparison to OCA alone in subjects with PBC who had an inadequate response or who were unable to tolerate ursodeoxycholic acid (UDCA).;Secondary Objective: The secondary objectives are to assess the effects of the combination of OCA and BZF in comparison to OCA alone in subjects with PBC who had an inadequate response or who were unable to tolerate UDCA on the following: - Safety and tolerability - Response and normalization rates of biochemical disease markers - Disease-specific symptoms as assessed by health-related quality of life questionnaires - Biomarkers of bile acid synthesis and homeostasis;Primary end point(s): Absolute change in ALP from baseline to Week 12 in the DB Treatment Period;Timepoint(s) of evaluation of this end point: week 12	—

Measure

Time frame

Main Objective: The primary objective is to assess the effects of the combination of OCA and BZF on alkaline phosphatase (ALP) in comparison to OCA alone in subjects with PBC who had an inadequate response or who were unable to tolerate ursodeoxycholic acid (UDCA).;Secondary Objective: The secondary objectives are to assess the effects of the combination of OCA and BZF in comparison to OCA alone in subjects with PBC who had an inadequate response or who were unable to tolerate UDCA on the following: - Safety and tolerability - Response and normalization rates of biochemical disease markers - Disease-specific symptoms as assessed by health-related quality of life questionnaires - Biomarkers of bile acid synthesis and homeostasis;Primary end point(s): Absolute change in ALP from baseline to Week 12 in the DB Treatment Period;Timepoint(s) of evaluation of this end point: week 12

—

Secondary

Measure	Time frame
Secondary end point(s): - Safety and tolerability - Response and normalization rates of biochemical disease markers - Disease-specific symptoms as assessed by health-related quality of life questionnaires - Biomarkers of bile acid synthesis and homeostasis;Timepoint(s) of evaluation of this end point: Baseline to End of study	—

Countries

Australia, Austria, Belgium, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Korea, Republic of, Latvia, Lithuania, Netherlands, Norway, Poland, Slovakia, Slovenia, Spain, Sweden, United Kingdom

Contacts

Public ContactPawel Waszka

Syneos Health

pawel.waszka@syneoshealth.com+48222564220

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026