Study on the Effects of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis Who Cannot Tolerate Ursodeoxycholic Acid

1 1

What is this study about?

This clinical trial is focused on studying a liver disease called Primary Biliary Cholangitis (PBC). PBC is a condition where the bile ducts in the liver become damaged, leading to a buildup of bile that can harm the liver. The study is testing the effects of two investigational drugs, obeticholic acid (also known as OCA) and bezafibrate (BZF), to see if they can help people with PBC who have not responded well to or cannot tolerate another treatment called ursodeoxycholic acid.

The purpose of the study is to evaluate how well the combination of OCA and BZF works compared to BZF alone in managing PBC. Participants in the study will receive either the combination of OCA and BZF, BZF alone, or a placebo. The study will last for about 53 weeks, during which participants will take the medication orally in the form of tablets. The researchers will monitor the participants’ health and liver function throughout the study to assess the safety and effectiveness of the treatment.

During the study, the main focus will be on measuring changes in a liver enzyme called alkaline phosphatase (ALP), which is often elevated in people with PBC. The study will also look at other liver enzymes and substances in the blood to understand the overall impact of the treatment. The goal is to find out if the combination of OCA and BZF can provide better outcomes for people with PBC compared to BZF alone.

1 joining the study

Upon joining the study, the patient is confirmed to have a diagnosis of Primary Biliary Cholangitis (PBC) and meets the necessary criteria, such as age and liver biochemistry values.

The patient must have been taking Ursodeoxycholic Acid (UDCA) for at least 12 months with a stable dose for at least 3 months before the start of the study, or not have taken UDCA for 3 months before the study begins.

2 randomization and treatment assignment

The patient is randomly assigned to one of the treatment groups in a double-blind manner, meaning neither the patient nor the researchers know which treatment the patient receives.

The treatments involve the use of Obeticholic Acid (OCA) and Bezafibrate (BZF), or a placebo.

3 medication administration

The patient takes the assigned medication orally. The specific medications include Bezalip (Bezafibrate), Ocaliva 10 mg (Obeticholic Acid), Bezalip Mono (Bezafibrate), and Ocaliva 5 mg (Obeticholic Acid), or their respective placebos.

The medications are administered in the form of film-coated tablets or prolonged-release tablets.

4 treatment duration

The treatment period lasts for 12 weeks, during which the patient continues to take the assigned medication as instructed.

5 monitoring and assessments

Throughout the study, the patient’s health and response to the medication are monitored. This includes regular assessments of liver function and other relevant health indicators.

The primary focus is on changes in Alkaline Phosphatase (ALP) levels from the start of the study to week 12.

6 study completion

At the end of the 12-week period, the patient’s response to the treatment is evaluated based on the changes in ALP and other health markers.

The study aims to determine the efficacy, safety, and tolerability of the combination of OCA and BZF in patients with PBC.

Who Can Join the Study?

You must have a definite or probable diagnosis of Primary Biliary Cholangitis (PBC). This is a liver condition that affects the bile ducts.
Your liver test results must show certain levels of alkaline phosphatase (ALP) and/or bilirubin. These are substances measured in blood tests to check liver function.
You must be at least 18 years old.
You should have been taking UDCA (a medication for PBC) for at least 12 months, with a stable dose for at least 3 months before the start of the study. If you are not taking UDCA, you should not have taken it for 3 months before the study begins.

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 has specific age requirements.
Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
Patients who have 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 participated in another clinical trial recently may not be eligible to participate.
Patients who have allergies or reactions to the study medications cannot participate.
Patients who have a history of alcohol or drug abuse may not be eligible to 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
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
KBC Zagreb	Zagreb	Croatia
General University Hospital Of Larissa	Larissa	Greece
University Of Debrecen	Debrecen	Hungary
RESEARCH SITE s.r.o	Plzen	Czechia
Hospital Clinic De Barcelona	Barcelona	Spain
Vilniaus universiteto ligonine Santaros klinikos VšĮ	Vilnius	Lithuania
Tartu University Hospital	Tartu	Estonia
Hospital General Universitario De Valencia	Valencia	Spain
Hepato-Gastroenterologie HK s.r.o.	Hradec Kralove	Czechia
Hopital Beaujon	Clichy	France
Urguusdqaf Mmnmflv Cioocy Hxwlopojejhzaoaax	Hamburg	Germany
Agtzhgldv Urh	Amsterdam	The Netherlands
Aiyqrzja Uvnuiguasr Hpoclbym	Lorenskog	Norway
Cfidihlu Hprfaakp Dqsvolz	Zagreb	Croatia
Aabldqzqt sojdiu	Trebovice	Czechia

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	02.10.2019
Croatia	Not recruiting	02.10.2019
Czechia	Not recruiting	02.10.2019
Estonia	Not recruiting	02.10.2019
France	Not recruiting	02.10.2019
Germany	Not recruiting	02.10.2019
Greece	Not recruiting	02.10.2019
Hungary	Not recruiting	02.10.2019
Lithuania	Not recruiting	02.10.2019
Norway	Not recruiting	02.10.2019
Spain	Not recruiting	02.10.2019
The Netherlands	Not recruiting	02.10.2019

Trial locations

Investigated drugs:

Obeticholic Acid is a medication used in this trial to help treat primary biliary cholangitis (PBC), a liver disease. It works by reducing inflammation and improving liver function. In this study, it is being tested in combination with another medication to see if it can help patients who have not responded well to other treatments.

Bezafibrate is another medication used in the trial for treating primary biliary cholangitis. It is known to help lower certain substances in the blood that can cause liver damage. The study is examining how effective it is when used alone and in combination with Obeticholic Acid.

Ursodeoxycholic Acid is a standard treatment for primary biliary cholangitis. However, some patients do not respond well to it or cannot tolerate it. This trial is focused on finding alternative treatments for those patients.

Primary Biliary Cholangitis (PBC) – This is a chronic liver disease characterized by the gradual destruction of the bile ducts within the liver. As the bile ducts are damaged, bile builds up in the liver, leading to inflammation and scarring. Over time, this can result in liver damage and impaired liver function. The disease often progresses slowly, and symptoms may include fatigue, itching, and jaundice. The exact cause of PBC is not well understood, but it is believed to involve an autoimmune component. It primarily affects middle-aged women and is considered a rare disease.

Trial ID:

2024-513762-18-00

Protocol code:

747-213

NCT ID:

NCT04594694

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on the Effects of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis Who Cannot Tolerate Ursodeoxycholic Acid

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?