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Study of Seladelpar Treatment in Patients with Primary Biliary Cholangitis and Compensated Cirrhosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Primary Biliary Cholangitis (PBC), a long-term liver disease that causes the bile ducts in the liver to become damaged. The study will test a medication called seladelpar in patients who have PBC with compensated cirrhosis, which means scarring of the liver that is still functioning. The purpose is to determine if seladelpar can improve health outcomes in these patients compared to placebo.

The medication will be given as oral capsules in two different strengths - 5 mg and 10 mg. The study will last for 156 weeks (about 3 years). During this time, researchers will monitor various aspects of liver health and complications that can occur with liver disease, such as ascites (fluid buildup in the abdomen), hepatic encephalopathy (brain function problems caused by liver disease), and esophageal varices (enlarged veins in the food pipe that can bleed).

This is a randomized, double-blind study, which means that patients will be assigned by chance to receive either seladelpar or placebo. Neither the patients nor the doctors will know which treatment each person is receiving. The study will track important health events including survival, need for liver transplantation, and hospitalizations related to liver complications. The medication's safety will also be carefully monitored throughout the study period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
You will receive either seladelpar or a placebo (inactive substance) in capsule form to take by mouth
The treatment will be assigned randomly, and neither you nor the doctor will know which treatment you are receiving
You will need to take the capsules daily for 156 weeks (approximately 3 years)
Step 2
Regular health monitoring
Your health will be monitored throughout the 156-week period
The medical team will track several important health indicators related to Primary Biliary Cholangitis (PBC), a liver condition
Regular assessments will check your liver function and overall health status
Step 3
Safety measures
If you are able to have children, you must use two forms of birth control during the study
One method must be a barrier contraceptive
Birth control must continue for 90 days after the last dose of study medication
Step 4
Health event monitoring
The medical team will monitor for specific health events including:
Changes in liver function scores (MELD Score)
Development of fluid in the abdomen (ascites) that requires treatment
Any hospital stays related to liver complications
Any need for liver transplantation
Step 5
Study completion
The study will end after 156 weeks of treatment
Final health assessments will be conducted
The medical team will evaluate how the treatment affected your liver condition

Who can join the trial?

12 criteria

Must be 18 years or older
Must have a confirmed diagnosis of Primary Biliary Cholangitis (PBC) - a chronic liver disease that affects the bile ducts
Must have evidence of cirrhosis - scarring of the liver tissue that indicates advanced liver disease
Must have a Child-Pugh Score of A or B - a scoring system that assesses the severity of liver disease
For women who can become pregnant:
- Must use at least one barrier contraceptive method (such as condoms)
- Must also use a second effective birth control method
- Must continue contraception during the study and for 90 days after the last dose
- For sexually active men with partners who can become pregnant:
  - Must use barrier contraception
  - Their female partners must use a second effective birth control method
  - Must continue contraception during the study and for 90 days after the last dose
  - Must be able to:
    
    Follow instructions for taking study medication
    Complete all required study assessments and visits

Who cannot join the trial?

14 criteria

History of liver transplantation or currently on a liver transplant waiting list
Presence of hepatocellular carcinoma (liver cancer)
Recent history of alcohol abuse (within past 2 years)
Active viral hepatitis (liver inflammation caused by viruses)
Known HIV infection
Pregnancy or breastfeeding
Severe kidney disease requiring dialysis
History of other serious medical conditions that could interfere with study participation
Current participation in another clinical trial or use of investigational drugs within 30 days
Unable to provide informed consent (clear understanding and agreement to participate)
History of poor compliance with medical treatments
Presence of ascites (fluid accumulation in the abdomen) requiring current treatment
Recent gastrointestinal bleeding within past 6 months
Current or recent history of hepatic encephalopathy (brain dysfunction caused by liver disease)

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Aarhus University Hospital
Verified
Aarhus, Denmark
Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium
Universitair Ziekenhuis Gent
Responsive
Gent, Belgium

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Investigated drugs

Seladelpar
is a medication being studied for treating Primary Biliary Cholangitis (PBC) in patients who also have compensated cirrhosis. It works by reducing inflammation and scarring in the liver. This medication is being tested to see if it can help prevent serious liver-related complications and improve survival in patients with this condition.
Placebo
is used in this trial as a comparison to determine how effective Seladelpar is. A placebo is an inactive substance that contains no medication but looks identical to the real treatment.

Seladelpar

What is already known about the treatment

Seladelpar - An investigational oral medication being studied for the treatment of Primary Biliary Cholangitis (PBC), a chronic liver disease. This drug belongs to the class of PPAR-delta agonists and works by reducing inflammation and bile acid production in the liver while improving lipid metabolism. Currently undergoing clinical trials to evaluate its efficacy in patients with PBC and compensated cirrhosis, with a focus on preventing disease progression and serious liver-related complications. The medication is being tested against placebo to assess its ability to improve survival outcomes and reduce the need for liver transplantation in patients with this condition.

Investigated diseases

Primary Biliary Cholangitis - A chronic liver disease that primarily affects women and slowly damages the bile ducts in the liver. The condition occurs when the bile ducts become inflamed, which leads to scarring and eventual blockage. As the ducts are damaged, bile builds up in the liver, causing further inflammation and scarring of liver tissue. The disease progresses gradually, starting with inflammation of the bile ducts and moving through stages of increasing liver damage. Over time, this process can affect the liver's ability to function properly. The disease typically develops slowly over many years.