Study on the Long-Term Safety of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis

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What is this study about?

This clinical trial is focused on studying Primary Biliary Cholangitis (PBC), a chronic disease that affects the liver. The study is evaluating a treatment that combines two medications: Obeticholic Acid and Bezafibrate. These medications are taken together in a single tablet form, known as OCA/BZF FDC, which stands for Fixed-Dose Combination of Obeticholic Acid and Bezafibrate.

The purpose of the study is to assess the long-term safety and tolerability of this combination treatment in individuals with PBC. Participants in the study will take the medication over an extended period, and researchers will monitor various health markers to ensure the treatment is safe and well-tolerated. These markers include levels of certain enzymes and substances in the blood that indicate liver function and bile acid balance.

The study is designed to provide valuable information about how well the treatment works over time and its impact on the health of individuals with PBC. Participants will be observed for changes in their condition, and the study will help determine if the treatment can effectively manage the symptoms and progression of PBC. The trial is open-label, meaning both the researchers and participants know which treatment is being administered, and it is a long-term study to gather comprehensive safety data.

1 introduction to the study

The study is designed to evaluate the long-term safety and tolerability of a fixed-dose combination tablet containing obeticholic acid and bezafibrate for individuals with primary biliary cholangitis (PBC).

Participants must have previously been involved in Study 747-213 or Study 747-214 and be actively taking the investigational product.

2 medication administration

The medication is administered orally in the form of a tablet.

Each tablet contains 5 mg of obeticholic acid and 400 mg of bezafibrate in a sustained-release (SR) formulation.

The frequency and duration of administration will be determined by the study protocol.

3 monitoring and assessments

Regular monitoring of biochemical disease markers will be conducted. These include ALP (alkaline phosphatase), GGT (gamma-glutamyl transferase), ALT (alanine aminotransferase), AST (aspartate aminotransferase), and bilirubin levels.

Biomarkers of bile acid synthesis and homeostasis, such as 7α-hydroxy-4-cholesten-3-one (C4) and bile acids, will also be assessed.

4 evaluation of primary endpoints

The primary endpoints focus on the response rates of reduction from baseline and normalization rates of ALP, GGT, ALT, AST, and bilirubin levels.

Changes from baseline in these markers will be evaluated to determine the effectiveness of the treatment.

5 evaluation of secondary endpoints

Secondary endpoints include changes from baseline in non-invasive markers of liver fibrosis and other health-related quality of life measures.

The study will also track the percentage of participants achieving specific biochemical targets and the time to first occurrence of significant clinical events such as death, liver transplant, or hospitalization.

6 study duration

The study is expected to continue until November 25, 2029.

Participants will be involved in the study for the duration specified in the protocol, with regular follow-ups and assessments as outlined.

Who Can Join the Study?

The study is for people with Primary Biliary Cholangitis (PBC), a liver condition.
Participants must have been part of Study 747-213 or Study 747-214 and are currently taking the study medication.
Both men and women can participate.
Participants must be within the specified age range, which includes adults and older adults.
The study includes individuals who may be considered part of a vulnerable population. This term refers to groups who might need special protection or care.

Who Cannot Join the Study?

Patients who have a different liver condition other than Primary Biliary Cholangitis (PBC) cannot participate. PBC is a disease that affects the bile ducts in the liver.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
Patients who have any other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate in the study.
Patients who have a history of allergic reactions to the study medication or similar medications cannot participate.
Patients who are currently participating in another clinical trial cannot participate in this study.
Patients who have a history of substance abuse or alcohol abuse cannot participate.
Patients who have had a liver transplant cannot participate in the study.
Patients who have certain abnormal blood test results that indicate severe liver damage cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Hochschule Hannover	Hanover	Germany
Centre Hospitalier Universitaire De Lille	Lille	France
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
General University Hospital Of Larissa	Larissa	Greece
University Of Debrecen	Debrecen	Hungary
RESEARCH SITE s.r.o	Plzen	Czechia
Vilniaus universiteto ligonine Santaros klinikos VšĮ	Vilnius	Lithuania
Tartu University Hospital	Tartu	Estonia
Hepato-Gastroenterologie HK s.r.o.	Hradec Kralove	Czechia
Hopital Beaujon	Clichy	France
Avngyxvyp Uvs	Amsterdam	The Netherlands
Aakotuyz Upozrksnyn Hodozetz	Lorenskog	Norway
Avlmopl Ujosr Sgzbazvbc Lrgotr Dd Blshjxh	Bologna	Italy
Chlivnan Hsfcaego Dxteabh	Zagreb	Croatia
Acmkhmthl sfehqu	Trebovice	Czechia

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	25.11.2024
Croatia	Not recruiting	25.11.2024
Czechia	Not recruiting	25.11.2024
Estonia	Not recruiting	25.11.2024
France	Not recruiting	25.11.2024
Germany	Not recruiting	25.11.2024
Greece	Not recruiting	25.11.2024
Hungary	Not recruiting	25.11.2024
Italy	Not recruiting	25.11.2024
Lithuania	Not recruiting	25.11.2024
Norway	Not recruiting	25.11.2024
The Netherlands	Not recruiting	25.11.2024

Trial locations

Investigated drugs:

Obeticholic Acid is a medication used to treat a liver condition known as primary biliary cholangitis. It works by reducing the production of bile acids in the liver, which can help decrease liver damage and improve liver function.

Bezafibrate is another medication used in the treatment of primary biliary cholangitis. It helps to lower certain fats in the blood and can improve liver function by reducing inflammation and bile acid levels.

In this clinical trial, these two medications are combined into a single tablet to evaluate their long-term safety and effectiveness when used together for treating primary biliary cholangitis.

Primary Biliary Cholangitis – Primary Biliary Cholangitis (PBC) is a chronic disease that affects the liver. It occurs when the bile ducts in the liver become damaged, leading to a buildup of bile. This buildup can cause inflammation and scarring of the liver tissue over time. As the disease progresses, it can lead to liver dysfunction. Symptoms may include fatigue, itchy skin, and yellowing of the skin and eyes. The exact cause of PBC is not well understood, but it is believed to involve an autoimmune response.

Trial ID:

2023-507771-22-01

Protocol code:

977-311

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Long-Term Safety of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?