BridgeMD
A study to learn about the effects and safety of obeticholic acid in combination with bezafibrate in participants with primary biliary cholangitis.
EU CTIS ID: 2024-513762-18-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- History or presence of other concomitant liver diseases
- Clinical complications of PBC
- History or presence of decompensating events
- History of or current gallbladder diseases
- If female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
- Treatment with commercially available OCA or participation in a previous study involving OCA
See the full eligibility criteria
- 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
- History or presence of other concomitant liver diseases
- Clinical complications of PBC
- History or presence of decompensating events
- History of or current gallbladder diseases
- If female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
- Treatment with commercially available OCA or participation in a previous study involving OCA
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- United Kingdom
- Australia
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; United Kingdom; Australia; Korea, Republic of. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.