133 Participants Needed

Obeticholic Acid + Bezafibrate for Primary Biliary Cirrhosis

Recruiting at 52 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Intercept Pharmaceuticals
Must be taking: Investigational product
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects with Primary Biliary Cholangitis (PBC).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

Is the combination of obeticholic acid and bezafibrate safe for humans?

Obeticholic acid has been associated with serious liver-related side effects, especially in patients with advanced liver disease, and its use is restricted in such cases. The combination with fibrates, like bezafibrate, has shown some adverse events, but detailed safety data is limited outside of clinical trials.12345

How is the drug combination of Obeticholic Acid and Bezafibrate unique for treating primary biliary cirrhosis?

The combination of Obeticholic Acid and Bezafibrate is unique because it targets patients with primary biliary cirrhosis who do not respond well to the standard treatment of ursodeoxycholic acid, offering a potential improvement in liver function tests.12567

What data supports the effectiveness of the drug combination of Obeticholic Acid and Bezafibrate for Primary Biliary Cirrhosis?

Research shows that combining obeticholic acid and fibrates can improve liver function tests in patients with primary biliary cholangitis who do not respond well to standard treatment. This suggests that the combination may be effective for primary biliary cirrhosis as well.12457

Who Is on the Research Team?

LS

Lynda Szczech, PhD

Principal Investigator

Intercept Pharmaceuticals Inc.

Are You a Good Fit for This Trial?

This trial is for individuals who have Primary Biliary Cholangitis (PBC) and are currently participating in either Study 747-213 or Study 747-214. It's designed to assess the long-term safety of a combined medication.

Inclusion Criteria

All subjects with PBC who participated and are actively taking investigational product in Study 747-213 or Study 747-214 are eligible to enroll in this study (977-311)

Exclusion Criteria

I have or had other liver diseases.
I have had liver failure or similar serious liver problems.
I am experiencing complications from primary biliary cholangitis.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a fixed-dose combination of Obeticholic Acid and Bezafibrate once daily

Up to 60 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants continue to receive the study medication to evaluate long-term safety and tolerability

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • Fixed-Dose Combination of Obeticholic Acid and Bezafibrate
Trial Overview The study tests a fixed-dose combination tablet containing Obeticholic Acid (5 mg) and Bezafibrate (400 mg). The goal is to understand how safe and tolerable this medication is over an extended period for PBC patients.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: OCA 5 mg + BZF 400 mg SRExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Intercept Pharmaceuticals

Lead Sponsor

Trials
29
Recruited
16,600+

Published Research Related to This Trial

The multicentric observational study compared the effects of obeticholic acid and fibrates in patients with primary biliary cholangitis, highlighting their efficacy in managing this liver disease.
Results indicated that obeticholic acid may provide superior benefits in improving liver function tests compared to fibrates, suggesting it could be a more effective treatment option for patients.
Continuing Medical Education Questions: November 2021.Richter, SJ.[2023]
In a study of 351 patients with primary biliary cholangitis, treatment with obeticholic acid (OCA) or fibrates significantly improved liver enzyme levels and the GLOBE score, indicating better liver health.
Adverse events occurred in 14.7% of patients, with the most common being pruritus, and treatment discontinuation was more frequent with fenofibrate due to intolerance, highlighting the need for careful monitoring of side effects.
Obeticholic Acid and Fibrates in Primary Biliary Cholangitis: Comparative Effects in a Multicentric Observational Study.Reig, A., Álvarez-Navascués, C., Vergara, M., et al.[2021]
Obeticholic acid (OCA) significantly reduced alkaline phosphatase (ALP) levels in patients with primary biliary cirrhosis who did not respond adequately to ursodeoxycholic acid, with reductions of 21%-25% compared to only 3% in the placebo group over 3 months.
The treatment was effective across all doses (10 mg, 25 mg, and 50 mg), but the 10 mg dose had the lowest incidence of pruritus, a common side effect, while maintaining significant biochemical improvements, which were sustained in a 12-month extension study.
Efficacy of obeticholic acid in patients with primary biliary cirrhosis and inadequate response to ursodeoxycholic acid.Hirschfield, GM., Mason, A., Luketic, V., et al.[2022]

Citations

Continuing Medical Education Questions: November 2021. [2023]
Obeticholic Acid and Fibrates in Primary Biliary Cholangitis: Comparative Effects in a Multicentric Observational Study. [2021]
Combination of fibrates with obeticholic acid is able to normalise biochemical liver tests in patients with difficult-to-treat primary biliary cholangitis. [2021]
Determinants of the effectiveness of bezafibrate combined with ursodeoxycholic acid in patients with primary biliary cholangitis. [2023]
Efficacy of obeticholic acid in patients with primary biliary cirrhosis and inadequate response to ursodeoxycholic acid. [2022]
Predictors of serious adverse events and non-response in cirrhotic patients with primary biliary cholangitis treated with obeticholic acid. [2023]
Combination therapy of bezafibrate and ursodeoxycholic acid for primary biliary cirrhosis: A meta-analysis. [2020]
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