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18 Primary Biliary Cirrhosis Trials
Power is an online platform that helps thousands of Primary Biliary Cirrhosis patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Elafibranor for Primary Biliary Cholangitis
Columbus, OhioThis trial is testing a drug called elafibranor on patients with Primary Biliary Cholangitis (PBC) who haven't responded to standard treatment. The goal is to see if elafibranor can lower a specific liver enzyme and improve symptoms. Initially, participants will receive different treatments, and later, all will receive elafibranor for an extended period. Elafibranor has shown promise in improving symptoms in previous trials.
Prior Safety Data
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18 - 75
Sex:All
161 Participants Needed
Linerixibat for Cholestasis
Columbus, OhioThis is an open-label, non-comparator, global, multi-center, long-term safety study for evaluating safety and tolerability of linerixibat in participants with cholestatic pruritus in primary biliary cholangitis (PBC) who participated in a prior clinical trial with linerixibat (BAT117123 \[NCT01899703\], 201000 GLIMMER \[NCT02966834\] (group 1) or 212620 GLISTEN \[NCT00210418\]) (group 2). All participants will receive open-label linerixibat for the duration of the study. The study duration is expected to last until the study's end or until linerixibat can be lawfully made available to participants. However, the total duration of study participation will vary by participant depending upon the time of entry relative to study end in their respective country.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18 - 80
Sex:All
245 Participants Needed
Linerixibat for Itching in Cholangitis
Columbus, OhioThis trial is testing a medication called linerixibat to see if it can help reduce severe itching in people with a liver condition called Primary Biliary Cholangitis (PBC). The study will compare the effects of linerixibat to check its effectiveness and safety.
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18 - 80
Sex:All
238 Participants Needed
Seladelpar for Primary Biliary Cholangitis
Liberty Township, OhioTo Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA).
The primary objective is to evaluate the effect of seladelpar treatment at Week 52 compared to placebo based on normalization of alkaline phosphatase (ALP) defined by a composite endpoint of ALP ≤ 1.0× upper limit of normal (ULN) and ≥ 15% decrease from baseline in PBC participants with an ALP value greater than ULN but less than 1.67× ULN.
Prior Safety Data
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Advanced PBC, Other Liver Diseases, HIV, Alcohol Abuse, Cancer, Others
Must Be Taking:Ursodeoxycholic Acid
90 Participants Needed
Saroglitazar Magnesium for Primary Biliary Cirrhosis
Cincinnati, OhioOpen-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Liver Diseases, Cirrhosis, Cardiovascular, Others
Must Not Be Taking:Thiazolidinediones, Fibrates, PPAR Agonists, Others
150 Participants Needed
Pemafibrate for Primary Biliary Cirrhosis
Cincinnati, OhioStudy to investigate the efficacy and safety of two doses of K-808 (pemafribate) in subjects with PBC.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Hepatitis C, Hepatitis B, Alcoholic Liver Disease, Autoimmune Hepatitis, NASH, Others
45 Participants Needed
Pemafibrate for Primary Biliary Cirrhosis
Cincinnati, OhioA Trial to Investigate the Pharmacokinetics (PK) Effects and Safety Profile of K-808 (Pemafibrate) in Primary Biliary Cholangitis (PBC) Subjects with and without Cirrhosis.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Breastfeeding, Drug Absorption Issues, Others
16 Participants Needed
Rosuvastatin for Liver Cirrhosis
Cleveland, OhioThis is a double-blind, phase 2 study to evaluate safety and efficacy of rosuvastatin in comparison to placebo after 2 years in patients with compensated cirrhosis.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Hepatocellular Carcinoma, Portal Thrombosis, Others
Must Not Be Taking:Statins, Amiodarone, Methotrexate, Others
256 Participants Needed
Volixibat for Primary Biliary Cholangitis
Cleveland, OhioThis trial is testing a medicine called volixibat that may help reduce itching in people with a liver disease that often causes severe itching. Volixibat works by blocking certain chemicals in the body that cause itching. The study also aims to see if the medicine can slow down the progression of the liver disease.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Decompensated Cirrhosis, Cholelithiasis, Liver Transplantation, Others
180 Participants Needed
Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (OCA) in participants with Primary Biliary Cholangitis (PBC).
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
60 Participants Needed
Obeticholic Acid + Bezafibrate for Primary Biliary Cirrhosis
Cleveland, OhioAn 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).
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 3
Age:18+
Sex:All
133 Participants Needed
Seladelpar for Primary Biliary Cholangitis
Cleveland, OhioThis trial is testing Seladelpar, a medication that may help people with a specific liver disease called Primary Biliary Cholangitis (PBC) and early-stage cirrhosis. The drug aims to reduce liver inflammation and damage, potentially improving liver health. Seladelpar has shown promising results in previous studies for PBC, despite initial safety concerns.
Prior Safety Data
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Decompensated Cirrhosis, Portal Vein Thrombosis, Others
318 Participants Needed
Elafibranor for Primary Biliary Cholangitis
Ypsilanti, MichiganThis trial is testing elafibranor, a medication for people with Primary Biliary Cholangitis (PBC) who do not respond to or cannot take the usual treatment. PBC is a liver disease that can lead to severe damage if untreated. Elafibranor aims to reduce harmful substances in the liver to prevent further damage. The study will also check if the medication is safe and helps with symptoms like itching and tiredness. Elafibranor is being tested as a new treatment option for PBC patients who do not respond to or cannot tolerate the standard treatments.
Prior Safety Data
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Hepatitis, HIV, Alcohol Abuse, Others
Must Not Be Taking:Fibrates, Glitazones, Corticosteroids, Others
276 Participants Needed
Elafibranor for Primary Biliary Cholangitis
Ypsilanti, MichiganThe participants in this study will have confirmed PBC with inadequate response or intolerance to Ursodeoxycholic acid (UDCA), which is a medication used in the management and treatment of cholestatic liver disease.
Primary biliary cholangitis is a slowly progressive disease characterised by damage of the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms.
Many patients with PBC may require a liver transplant or may die if the disease progresses and a liver transplant is not done. This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment).
The main aim of this study is to determine if elafibranor is better than placebo in reducing ALP levels to a normal value. High ALP levels in the blood can indicate liver disease.
There will be three periods in this study: A screening period (up to 8 weeks) to assess whether the participant can take part; a treatment period (up to 52 weeks) where eligible participants will be grouped as per their blood ALP levels and randomly assigned to either receive elafibranor or placebo, and a follow-up period (4 weeks) where participants' health will be monitored.
Participants will be twice as likely to receive elafibranor than placebo (2:1 ratio).
Participants will undergo blood sampling, urine collections, physical examinations, clinical evaluations, electrocardiograms (ECG: recording of the electrical activity of heart), ultrasound examinations (a noninvasive test that passes a probe over skin to look at the bladder, urinary tract, and liver), and Fibroscan® examinations (a noninvasive test that passes a probe on skin to measure stiffness of the liver).
They will also be asked to fill in questionnaires. Each participant will be in this study for up to 64 weeks (15 months).
Prior Safety Data
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Other Liver Diseases, Cirrhosis, HIV, Others
Must Be Taking:Ursodeoxycholic Acid
72 Participants Needed
Seladelpar for Primary Biliary Cholangitis
Pittsburgh, PennsylvaniaAn Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
No Placebo Group
Prior Safety Data
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18 - 75
Sex:All
500 Participants Needed
CNP-104 for Primary Biliary Cholangitis
Detroit, MichiganThis trial tests a new drug, CNP-104, in adults with a liver disease called primary biliary cholangitis. The drug is given through a vein to check its safety and effectiveness. The study will monitor patients for a period of time.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:18 - 75
Sex:All
42 Participants Needed
Saroglitazar Magnesium for Primary Biliary Cholangitis
Indianapolis, IndianaThis trial tests Saroglitazar Magnesium tablets on patients with Primary Biliary Cholangitis to see if it can help their liver work better and reduce inflammation.
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Age:18 - 75
Sex:All
186 Participants Needed
Seladelpar for Liver Disease
Novi, MichiganThe Effect of Hepatic Impairment on The Pharmacokinetics of Seladelpar: An Open-Label Study Following Oral Dosing of Seladelpar to Subjects with Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 80
Sex:All
24 Participants Needed
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Frequently Asked Questions
How much do Primary Biliary Cirrhosis clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Primary Biliary Cirrhosis clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Primary Biliary Cirrhosis trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Primary Biliary Cirrhosis is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Primary Biliary Cirrhosis medical study ?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Primary Biliary Cirrhosis clinical trials ?
Most recently, we added Pemafibrate for Primary Biliary Cirrhosis, Saroglitazar Magnesium for Primary Biliary Cirrhosis and Elafibranor for Primary Biliary Cholangitis to the Power online platform.