NCT04594694CompletedPhase 2
A study to learn about the effects and safety of obeticholic acid in combination with bezafibrate in participants with primary biliary cholangitis.
A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid
Source: EU CTIS (euclinicaltrials.eu) · Last updated 18 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The primary objective is to assess the effects of the combination of OCA and BZF on alkaline phosphatase (ALP) in comparison to BZF alone in subjects with PBC.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 65 (actual)
- First submitted
- 2 May 2024
- Start date
- 20 Sept 2019
- Lead sponsor
- Intercept Pharmaceuticals Inc.
- Diseases
- Primary biliary cholangitis
- NCT number
- NCT04594694
- EU CT number
- 2024-513762-18-00
- EudraCT number
- 2018-002575-17
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 65
- 20 sites in 12 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History or presence of other concomitant liver diseases
- Treatment with commercially available OCA or participation in a previous study involving OCA
Other illness
- History of or current gallbladder diseases
Lab values
- If female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
Other
- Clinical complications of PBC
- History or presence of decompensating events
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
Who the study is looking for
- A definite or probable diagnosis of PBC (consistent with the EASL and the AASLD guidelines [Lindor 2009, EASL 2017])
- Qualifying ALP and/or bilirubin liver biochemistry values
- Age ≥18 years
- Taking UDCA for at least 12 months (stable dose for ≥3 months) before Day 1 or no UDCA for 3 months before Day 1
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Erasme Coordinator of this site? Confirm its status | Anderlecht | Belgium | Completed |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| Hepato-Gastroenterologie HK, s.r.o. Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Completed |
| Research Site s.r.o. Coordinator of this site? Confirm its status | Plzen 3 | Czechia | Completed |
| Artroscan s.r.o. Coordinator of this site? Confirm its status | Trebovice | Czechia | Completed |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Completed |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Completed |
| Tartu University Hospital Coordinator of this site? Confirm its status | Tartu Linn | Estonia | Completed |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Creteil Cedex | France | Completed |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Completed |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Completed |
| General University Hospital of Larissa Coordinator of this site? Confirm its status | Larissa | Greece | Completed |
| Clinical Hospital Dubrava Coordinator of this site? Confirm its status | Grad Zagreb | Croatia | Completed |
| University Hospital Centre Zagreb Coordinator of this site? Confirm its status | Zagreb | Croatia | Completed |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Completed |
| Vilniaus universiteto ligonine Santaros klinikos VšĮ Coordinator of this site? Confirm its status | Vilnius | Lithuania | Completed |
| VUMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
| Akershus University Hospital Coordinator of this site? Confirm its status | Loerenskog | Norway | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.