Clinical Trials for Primary Biliary Cholangitis
Primary biliary cholangitis (PBC) is a chronic liver disease where bile ducts become damaged, leading to bile buildup and potential liver harm. Currently, 12 clinical trials are testing various medications for patients with PBC, particularly those who haven’t responded well to standard treatment or cannot tolerate it. These trials are taking place across multiple European countries and are examining drugs such as elafibranor, seladelpar, bezafibrate, golexanolone, linerixibat, obeticholic acid, and saroglitazar magnesium. (Also known as: primary biliary cirrhosis)
Clinical trial locations
- Austria
- Belgium
- Study of Elafibranor for Adults with Primary Biliary Cholangitis
- Study of Seladelpar Treatment in Patients with Primary Biliary Cholangitis and Compensated Cirrhosis
- Study on Long-term Safety of Linerixibat for Treating Itchy Skin in Patients with Primary Biliary Cholangitis
- Study on Elafibranor for Patients with Primary Biliary Cholangitis Not Responding to Ursodeoxycholic Acid
- Study on the Effects of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis Who Cannot Tolerate Ursodeoxycholic Acid
- Study on the Long-Term Safety of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis
- Study on the Long-Term Safety of Seladelpar for Patients with Primary Biliary Cholangitis
- Bulgaria
- Croatia
- Czechia
- Study of Elafibranor for Adults with Primary Biliary Cholangitis
- Study of Seladelpar Treatment in Patients with Primary Biliary Cholangitis and Compensated Cirrhosis
- Study on Long-term Safety of Linerixibat for Treating Itchy Skin in Patients with Primary Biliary Cholangitis
- Study of Elafibranor in Adults with Primary Biliary Cholangitis Who Don’t Respond Well to or Cannot Tolerate Ursodeoxycholic Acid Treatment
- Study on the Effects of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis Who Cannot Tolerate Ursodeoxycholic Acid
- Study on the Long-Term Safety of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis
- Study on the Long-Term Safety of Seladelpar for Patients with Primary Biliary Cholangitis
- Denmark
- Estonia
- France
- Study of Elafibranor for Adults with Primary Biliary Cholangitis
- Study of Seladelpar Treatment in Patients with Primary Biliary Cholangitis and Compensated Cirrhosis
- Study on Bezafibrate for Patients with Primary Biliary Cholangitis Not Responding Well to Ursodeoxycholic Acid
- Study on Long-term Safety of Linerixibat for Treating Itchy Skin in Patients with Primary Biliary Cholangitis
- Study of Elafibranor in Adults with Primary Biliary Cholangitis Who Don’t Respond Well to or Cannot Tolerate Ursodeoxycholic Acid Treatment
- Study on Elafibranor for Patients with Primary Biliary Cholangitis Not Responding to Ursodeoxycholic Acid
- Study on the Effects of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis Who Cannot Tolerate Ursodeoxycholic Acid
- Study on the Long-Term Safety of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis
- Study on the Long-Term Safety of Seladelpar for Patients with Primary Biliary Cholangitis
- Germany
- Study of Seladelpar Treatment in Patients with Primary Biliary Cholangitis and Compensated Cirrhosis
- Study on Golexanolone for Patients with Primary Biliary Cholangitis Experiencing Fatigue and Cognitive Dysfunction
- Study on Long-term Safety of Linerixibat for Treating Itchy Skin in Patients with Primary Biliary Cholangitis
- Study of Elafibranor in Adults with Primary Biliary Cholangitis Who Don’t Respond Well to or Cannot Tolerate Ursodeoxycholic Acid Treatment
- Study on Elafibranor for Patients with Primary Biliary Cholangitis Not Responding to Ursodeoxycholic Acid
- Study on the Effects of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis Who Cannot Tolerate Ursodeoxycholic Acid
- Study on the Long-Term Safety of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis
- Study on the Long-Term Safety of Seladelpar for Patients with Primary Biliary Cholangitis
- Greece
- Study of Elafibranor for Adults with Primary Biliary Cholangitis
- Study of Seladelpar Treatment in Patients with Primary Biliary Cholangitis and Compensated Cirrhosis
- Study on Golexanolone for Patients with Primary Biliary Cholangitis Experiencing Fatigue and Cognitive Dysfunction
- Study on Long-term Safety of Linerixibat for Treating Itchy Skin in Patients with Primary Biliary Cholangitis
- Study on the Effects of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis Who Cannot Tolerate Ursodeoxycholic Acid
- Study on the Long-Term Safety of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis
- Study on the Long-Term Safety of Seladelpar for Patients with Primary Biliary Cholangitis
- Hungary
- Study of Elafibranor for Adults with Primary Biliary Cholangitis
- Study of Seladelpar Treatment in Patients with Primary Biliary Cholangitis and Compensated Cirrhosis
- Study on Golexanolone for Patients with Primary Biliary Cholangitis Experiencing Fatigue and Cognitive Dysfunction
- Study on the Effects of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis Who Cannot Tolerate Ursodeoxycholic Acid
- Study on the Long-Term Safety of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis
- Study on the Long-Term Safety of Seladelpar for Patients with Primary Biliary Cholangitis
- Iceland
- Italy
- Study of Elafibranor for Adults with Primary Biliary Cholangitis
- Study of Seladelpar Treatment in Patients with Primary Biliary Cholangitis and Compensated Cirrhosis
- Study on Golexanolone for Patients with Primary Biliary Cholangitis Experiencing Fatigue and Cognitive Dysfunction
- Study on Long-term Safety of Linerixibat for Treating Itchy Skin in Patients with Primary Biliary Cholangitis
- Study of Elafibranor in Adults with Primary Biliary Cholangitis Who Don’t Respond Well to or Cannot Tolerate Ursodeoxycholic Acid Treatment
- Study on Elafibranor for Patients with Primary Biliary Cholangitis Not Responding to Ursodeoxycholic Acid
- Study on the Effects of Bezafibrate and Obeticholic Acid for Patients with Primary Biliary Cholangitis
- Study on the Long-Term Safety of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis
- Study on the Long-Term Safety of Seladelpar for Patients with Primary Biliary Cholangitis
- Lithuania
- Study of Elafibranor for Adults with Primary Biliary Cholangitis
- Study on the Effects of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis Who Cannot Tolerate Ursodeoxycholic Acid
- Study on the Long-Term Safety of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis
- Netherlands
- Study on the Effects of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis Who Cannot Tolerate Ursodeoxycholic Acid
- Study on the Long-Term Safety of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis
- Study on the Long-Term Safety of Seladelpar for Patients with Primary Biliary Cholangitis
- Norway
- Poland
- Study of Elafibranor for Adults with Primary Biliary Cholangitis
- Study of Seladelpar Treatment in Patients with Primary Biliary Cholangitis and Compensated Cirrhosis
- Study on Bezafibrate for Patients with Primary Biliary Cholangitis Not Responding Well to Ursodeoxycholic Acid
- Study on Long-term Safety of Linerixibat for Treating Itchy Skin in Patients with Primary Biliary Cholangitis
- Study of Elafibranor in Adults with Primary Biliary Cholangitis Who Don’t Respond Well to or Cannot Tolerate Ursodeoxycholic Acid Treatment
- Study on the Long-Term Safety of Seladelpar for Patients with Primary Biliary Cholangitis
- Portugal
- Romania
- Study of Elafibranor for Adults with Primary Biliary Cholangitis
- Study of Seladelpar Treatment in Patients with Primary Biliary Cholangitis and Compensated Cirrhosis
- Study of Elafibranor in Adults with Primary Biliary Cholangitis Who Don’t Respond Well to or Cannot Tolerate Ursodeoxycholic Acid Treatment
- Study on the Long-Term Safety of Seladelpar for Patients with Primary Biliary Cholangitis
- Slovakia
- Spain
- Study of Elafibranor for Adults with Primary Biliary Cholangitis
- Study of Seladelpar Treatment in Patients with Primary Biliary Cholangitis and Compensated Cirrhosis
- Study on Golexanolone for Patients with Primary Biliary Cholangitis Experiencing Fatigue and Cognitive Dysfunction
- Study on Long-term Safety of Linerixibat for Treating Itchy Skin in Patients with Primary Biliary Cholangitis
- Study of Elafibranor in Adults with Primary Biliary Cholangitis Who Don’t Respond Well to or Cannot Tolerate Ursodeoxycholic Acid Treatment
- Study on Elafibranor for Patients with Primary Biliary Cholangitis Not Responding to Ursodeoxycholic Acid
- Study on the Effects of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis Who Cannot Tolerate Ursodeoxycholic Acid
- Study on the Long-Term Safety of Seladelpar for Patients with Primary Biliary Cholangitis
Study of Elafibranor for Adults with Primary Biliary Cholangitis
This long-term trial is evaluating elafibranor, taken as a daily 80 mg tablet, in people with PBC and cirrhosis. The main goal is to assess how long participants remain free from serious health events related to their liver condition over approximately 3.5 years.
Who can participate: Adults 18 years or older with confirmed PBC and cirrhosis classified as Child-Pugh A or B can join. Participants must use appropriate contraception methods throughout the study.
Who cannot participate: People with other serious liver diseases besides PBC, severe heart or kidney problems, uncontrolled diabetes, previous liver transplants, or certain types of cancer are excluded. Pregnant or breastfeeding women, those with alcohol or drug abuse history in the past year, and people currently in another clinical trial cannot participate.
Treatment approach: Participants are randomly assigned to receive either elafibranor or placebo tablets. Regular health monitoring occurs every six months through physical exams, blood tests, and heart function assessments to track liver health and any side effects.
Study of Seladelpar Treatment in Patients with Primary Biliary Cholangitis and Compensated Cirrhosis
This 156-week study is testing seladelpar in two different doses (5 mg and 10 mg capsules) for people with PBC and compensated cirrhosis (liver scarring that is still functioning). The study aims to determine if seladelpar can improve survival and prevent serious liver complications.
Who can participate: Adults 18 years or older with confirmed PBC and compensated cirrhosis (Child-Pugh Score A or B) are eligible. Participants must use two forms of birth control, including one barrier method, during the study and for 90 days after the last dose.
Who cannot participate: People with previous liver transplants, liver cancer, recent alcohol abuse, active viral hepatitis, HIV infection, severe kidney disease requiring dialysis, or serious medical conditions that might interfere with the study are excluded. Pregnant, breastfeeding, or those currently experiencing fluid buildup in the abdomen or recent gastrointestinal bleeding cannot participate.
Treatment approach: Participants receive either seladelpar or placebo in a double-blind setting, meaning neither participants nor doctors know who receives which treatment. Regular monitoring tracks liver function scores, development of complications, hospital stays, and any need for liver transplantation.
Study on Bezafibrate for Patients with Primary Biliary Cholangitis Not Responding Well to Ursodeoxycholic Acid
This 24-month trial is testing bezafibrate at two doses (200 mg and 400 mg) for people with PBC who haven’t responded well to ursodeoxycholic acid. The study aims to determine if bezafibrate can normalize liver enzyme levels.
Who can participate: Adults between 18 and 79 years old with confirmed PBC who have been on stable ursodeoxycholic acid therapy for at least 12 months can join. Women who can become pregnant must use at least one barrier method of birth control. Participants must be enrolled in a social security system (except AME).
Who cannot participate: People without PBC or a non-optimal response to ursodeoxycholic acid, those outside the specified age range, or individuals from vulnerable populations requiring special protection cannot participate.
Treatment approach: The first 12 months involves a double-blind phase where participants receive either bezafibrate (200 mg or 400 mg) or placebo. This is followed by a 12-month extension where all participants receive bezafibrate without placebo. Regular monitoring focuses on liver function tests and symptom changes, particularly itching intensity.
Study on Golexanolone for Patients with Primary Biliary Cholangitis Experiencing Fatigue and Cognitive Dysfunction
This study is evaluating golexanolone capsules for people with PBC who experience significant tiredness and problems with thinking clearly. The trial has two parts: Part A tests a 40 mg dose twice daily for 5 days, while Part B tests two different dose levels twice daily for 28 days.
Who can participate: Men and women aged 18-75 with confirmed PBC, significant fatigue (score of 29 or higher), and cognitive symptoms (score of 16 or higher) can participate. If on standard PBC treatment, it must be stable for at least 3 months. Women who can become pregnant must have a negative pregnancy test and use reliable birth control during the study and for one month after.
Who cannot participate: People with other liver diseases besides PBC, severe liver damage (Child-Pugh class B or C), other serious medical conditions, those who are pregnant or breastfeeding, or those who participated in another clinical trial within the last 30 days cannot join. People with known allergies to the study medication or unable to follow study procedures are also excluded.
Treatment approach: Participants take golexanolone orally, with Part A involving 5 days of treatment and Part B involving 28 days. Regular monitoring tracks safety, side effects, and changes in quality of life, including energy levels and cognitive function.
Study on Long-term Safety of Linerixibat for Treating Itchy Skin in Patients with Primary Biliary Cholangitis
This trial is focused on evaluating the long-term safety of linerixibat tablets for treating cholestatic pruritus (severe itching) in people with PBC. The study monitors participants over an extended period with regular check-ups.
Who can participate: Adults aged 18-80 with confirmed PBC and a history of itching who participated in a previous linerixibat study and completed its main treatment period can join. Female participants must not be pregnant or breastfeeding and must use acceptable birth control during the study and for at least 4 weeks after the last dose.
Who cannot participate: People with cholestasis or pruritus related to PBC, those outside the age range of 18-65 years, or individuals from vulnerable populations are excluded.
Treatment approach: Participants take linerixibat tablets orally, with assessments occurring regularly at Day 1, Week 1, and then monthly for up to 48 months. The study monitors the frequency and severity of any adverse events and their effects on quality of life, including sleep and fatigue. A follow-up phone call occurs between Day 7 and Day 14 after the final dose.
Study of Elafibranor in Adults with Primary Biliary Cholangitis Who Don’t Respond Well to or Cannot Tolerate Ursodeoxycholic Acid Treatment
This 52-week study is testing elafibranor 80 mg film-coated tablets in adults with PBC who haven’t responded well to or cannot tolerate ursodeoxycholic acid. The goal is to determine if elafibranor can normalize liver enzyme levels.
Who can participate: Adults 18 years or older with confirmed PBC and alkaline phosphatase levels above normal but not more than 1.67 times the upper limit can join. If taking ursodeoxycholic acid, participants must have been on it for at least 12 months with a stable dose for 6 months, or if unable to take it, must have stopped at least 3 months ago. Men must use condoms and not donate sperm, while women who can become pregnant must use effective contraception and have negative pregnancy tests.
Who cannot participate: People under 18, those who are pregnant or breastfeeding, with liver transplant history, cirrhosis with complications, other liver diseases besides PBC, severe kidney problems, uncontrolled high blood pressure, recent heart problems, active cancer, recent alcohol or drug abuse, or current participation in another trial are excluded.
Treatment approach: Participants receive either elafibranor or placebo once daily for 52 weeks. Regular check-ups occur at weeks 4, 12, 24, 36, and 52, with blood tests monitoring liver function, alkaline phosphatase, and bilirubin levels. The study also tracks itching severity and quality of life through questionnaires.
Study on Elafibranor for Patients with Primary Biliary Cholangitis Not Responding to Ursodeoxycholic Acid
This 52-week trial is evaluating elafibranor 80 mg film-coated tablets for people with PBC who haven’t responded well to or cannot tolerate ursodeoxycholic acid. The study includes an optional open-label extension where all participants receive elafibranor to assess long-term safety and benefits.
Who can participate: Adults aged 18-75 with confirmed PBC, alkaline phosphatase levels at least 1.67 times the upper limit of normal, total bilirubin no more than 2 times the upper limit, and adequate recorded itch severity values can join. If taking ursodeoxycholic acid, it must be for at least 12 months with a stable dose for 3 months, or not taken for at least 3 months. Those on certain other medications must have stable doses for at least 3 months. Participants must use contraception methods following local regulations.
Who cannot participate: People with other serious liver diseases besides PBC, previous liver transplants, severe heart problems, uncontrolled diabetes, certain cancers, pregnancy or breastfeeding, current participation in another trial, known medication allergies, severe kidney problems, certain infections, or recent alcohol or drug abuse are excluded.
Treatment approach: Participants are randomly assigned to receive either elafibranor or placebo daily for 52 weeks. Regular monitoring includes physical exams, blood tests, and assessments of itching severity and quality of life. After the 52-week period, participants may continue in an open-label extension where everyone receives elafibranor.
Study on the Effects of Bezafibrate and Obeticholic Acid for Patients with Primary Biliary Cholangitis
This study is testing the combination of obeticholic acid and bezafibrate tablets compared to bezafibrate alone in people with PBC. The main focus is assessing changes in alkaline phosphatase levels over 12 weeks.
Who can participate: Adults with confirmed or likely PBC diagnosis, specific liver chemical levels (alkaline phosphatase and bilirubin), who have been taking ursodeoxycholic acid for at least 12 months or not taking it for at least 3 months before the study can participate. Both men and women are eligible, including vulnerable populations.
Who cannot participate: People with other serious liver diseases besides PBC, previous liver transplants, severe heart or kidney problems, those who are pregnant or breastfeeding, currently in another clinical trial, with alcohol or drug abuse history, or any condition that study doctors believe would make participation unsafe are excluded.
Treatment approach: Participants receive either the combination of obeticholic acid and bezafibrate or bezafibrate alone in tablet form. Regular monitoring occurs throughout the 12-week treatment period to evaluate safety, tolerability, and changes in liver enzymes and lipid levels.
Study on the Effects of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis Who Cannot Tolerate Ursodeoxycholic Acid
This 53-week study is evaluating the combination of obeticholic acid and bezafibrate compared to bezafibrate alone or placebo in people with PBC who haven’t responded well to or cannot tolerate ursodeoxycholic acid. The focus is on measuring changes in alkaline phosphatase levels.
Who can participate: Adults at least 18 years old with confirmed PBC diagnosis, specific alkaline phosphatase and/or bilirubin levels, who have been taking ursodeoxycholic acid for at least 12 months with a stable dose for 3 months, or not taken it for 3 months before the study can join.
Who cannot participate: People with different liver conditions other than PBC, those not within the specified age range, unable to follow study procedures or take medications as required, with other serious health conditions, pregnant or breastfeeding, recent participation in another trial, medication allergies, or history of alcohol or drug abuse are excluded.
Treatment approach: Participants are randomly assigned in a double-blind manner to receive obeticholic acid and bezafibrate, bezafibrate alone, or placebo in tablet form for 12 weeks. Regular monitoring assesses alkaline phosphatase levels, other liver enzymes, and overall health status throughout the treatment period.
Study on the Long-Term Safety of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis
This long-term study is evaluating the safety and tolerability of a fixed-dose combination tablet containing both obeticholic acid (5 mg) and bezafibrate (400 mg) in people with PBC. The study is open-label, meaning both researchers and participants know which treatment is being administered, and continues until November 2029.
Who can participate: People with PBC who previously participated in Study 747-213 or Study 747-214 and are currently taking the investigational product can join. Both men and women within specified age ranges, including adults and older adults, are eligible, including those from vulnerable populations.
Who cannot participate: People with different liver conditions other than PBC, those outside the specified age range, unable to follow study procedures or take medication as required, with other serious health conditions, pregnant or breastfeeding, with allergic reactions to the study medication, currently in another clinical trial, with substance or alcohol abuse history, previous liver transplants, or certain abnormal blood test results indicating severe liver damage are excluded.
Treatment approach: Participants take one tablet containing obeticholic acid and bezafibrate orally, with the frequency determined by the study protocol. Regular monitoring tracks biochemical disease markers including alkaline phosphatase, liver enzymes, and bilirubin levels, as well as bile acid synthesis markers and quality of life measures.
Summary
These 12 clinical trials for primary biliary cholangitis represent a comprehensive research effort focused on finding effective treatments for patients who don’t respond well to standard therapy with ursodeoxycholic acid. The trials span multiple European countries, with particularly strong representation in France, Germany, Italy, and Spain, reflecting collaborative international efforts to address this chronic liver condition.
A notable pattern is the focus on several key medications: elafibranor appears in multiple trials testing different patient populations and treatment durations, while combination approaches using obeticholic acid and bezafibrate are being evaluated for both their effectiveness and long-term safety. Seladelpar is being studied specifically for patients with more advanced disease (compensated cirrhosis), and newer medications like golexanolone and saroglitazar magnesium are being tested for specific symptoms such as fatigue and cognitive dysfunction.
Most trials emphasize careful patient monitoring over extended periods, with some lasting up to 3.5 years, demonstrating the commitment to understanding long-term effects and safety. The studies employ rigorous methods including double-blind, placebo-controlled designs to ensure reliable results. Common exclusion criteria across trials reflect the need to ensure patient safety, particularly regarding pregnancy, severe organ dysfunction, and other serious medical conditions.
These trials collectively aim to expand treatment options for the many patients with primary biliary cholangitis who need alternatives or additions to current standard therapy, potentially improving liver function, reducing symptoms like itching and fatigue, and preventing disease progression.
