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New treatment option for Primary Biliary Cholangitis (PBC)
Official title A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
ClinicalTrials.gov ID: NCT06016842
What this study is testing
What is Elafibranor?
Elafibranor is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for primary biliary cholangitis (pbc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring of the liver). PBC is a slowly progressive disease, characterised by damage to the bile ducts in the liver, leading to a build-up of bile acids which causes further damage.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female participants must be ≥18 years of age at the time of signing the informed consent.
- Participants with a definite or probable diagnosis of primary biliary cholangitis (PBC)
- Participants with cirrhosis at SV1. Participants must be Child Pugh A or Child Pugh B.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in...
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)...
You likely can't join if
- History or presence of other concomitant liver disease including but not limited to:
- i) Primary sclerosing cholangitis (PSC).
- ii) Autoimmune hepatitis (AIH) by simplified Diagnostic Criteria of the International Autoimmune Hepatitis Group (IAIHG) ≥6, or if treated for an...
- iii) Positive hepatitis B surface antigen (HBsAg). Participants with negative HBsAg and positive hepatitis B core antibody (HBcAb) may be eligible if...
- iv) Hepatitis C virus (HCV) infection defined by positive anti-HCV antibody and positive HCV ribonucleic acid (RNA) (Note: Participants with positive...
- v) Alcohol-associated liver disease (ALD).
See the full eligibility criteria
Who can join
- Male or female participants must be ≥18 years of age at the time of signing the informed consent.
- Participants with a definite or probable diagnosis of primary biliary cholangitis (PBC)
- Participants with cirrhosis at SV1. Participants must be Child Pugh A or Child Pugh B.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
What rules you out
- History or presence of other concomitant liver disease including but not limited to:
- i) Primary sclerosing cholangitis (PSC).
- ii) Autoimmune hepatitis (AIH) by simplified Diagnostic Criteria of the International Autoimmune Hepatitis Group (IAIHG) ≥6, or if treated for an overlap of PBC with AIH, or if there is clinical suspicion and evidence...
- iii) Positive hepatitis B surface antigen (HBsAg). Participants with negative HBsAg and positive hepatitis B core antibody (HBcAb) may be eligible if hepatitis B virus deoxyribonucleic acid (HBV DNA) is negative.
- iv) Hepatitis C virus (HCV) infection defined by positive anti-HCV antibody and positive HCV ribonucleic acid (RNA) (Note: Participants with positive anti-HCV antibody due to previously treated HCV infection, may be...
- v) Alcohol-associated liver disease (ALD).
- vi) Nonalcoholic steatohepatitis (NASH).
- vii) Other chronic liver diseases, such as alpha-1 antitrypsin deficiency.
- History or presence of clinically significant hepatic decompensation, including:
- i) History of liver transplantation, current placement on a liver transplant list, current model for end-stage liver disease including (MELD) 3.0 score \>12 due to hepatic impairment.
- ii) Evidence of complications of cirrhosis, including hepatic decompensation or evidence of significant portal hypertension complications including presence of uncontrolled ascites; history of variceal bleeding or...
- iii) Hepatorenal syndrome (HRS) (type I or II ). vi) Hospitalisation for liver-related complication within 12 weeks prior to SV1.
- Known history of human immunodeficiency virus (HIV) infection or having a positive confirmatory test for HIV type 1 or 2.
- Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget's disease).
- Evidence of any other unstable or untreated clinically significant immunological, endocrine, hematologic, gastrointestinal, neurological, or psychiatric disease as evaluated by the investigator; other clinically...
- Non-hepatic medical conditions that may diminish life expectancy to \<2 years, including known cancers.
- History of hepatocellular carcinoma.
- Alpha-fetoprotein (AFP) \>20 ng/mL with 4-phase liver computerised tomography (CT) or magnetic resonance imaging (MRI) imaging suggesting presence of hepatocellular carcinoma.
- Known malignancy or history of malignancy within the last 5 years. Participants with non-melanoma skin cancer, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially...
- Administration of the following medications is prohibited during the study, and prior to the study as per the timelines specified below: i) 3 months prior to baseline: fibrates, seladelpar, glitazones, obeticholic acid...
- Participants who are currently participating in, plan to participate in, or have participated in an investigational drug study or medical device study containing active substance within 30 days or 5 half-lives...
- Electrocardiogram (ECG) with QT interval corrected by Fridericia's formula (QTcF) \>450 msec in males or QTcF \>470 msec in females for participants without bundle branch block. For participants with bundle branch block...
- Total bilirubin (TB) \>5x ULN
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>5x ULN at SV1
- Creatinine phosphokinase (CPK) \>2x ULN.
- Platelet count \<50,000/μL
- International normalised ratio (INR) \>1.8 in the absence of anticoagulant therapy.
- Estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m2 per the Modification of Diet in Renal Disease (MDRD)-6 Study formula at SV1.
- Significant renal disease, including nephritic syndrome, chronic kidney disease (CKD) (defined as participants with evidence of significantly impaired kidney function or underlying kidney injury).
- For female participants: known current pregnancy, or has a positive serum pregnancy test, or is breastfeeding.
- Participants unwilling or unable to be abstinent from alcohol during the study.
- History of alcohol abuse, or other substance abuse within 1 year prior to SV1.
- Known hypersensitivity to elafibranor or to any of the excipients of the investigational product(s).
- Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
- Any other condition that, in the opinion of the investigator, would interfere with study participation or completion, or would put the participant at risk, including a potential participant assessed as being at high...
- Alkaline phosphatase (ALP) ≥10x ULN.
- Albumin \<2.8 g/dL due to impaired hepatic function.
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Coronado, California, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- Aurora, Colorado, United States
- Colorado Springs, Colorado, United States
- Englewood, Colorado, United States
- Littleton, Colorado, United States
- Miami, Florida, United States
- Pembroke Pines, Florida, United States
- Tampa, Florida, United States
- Kansas City, Kansas, United States
- Shreveport, Louisiana, United States
- Ann Arbor, Michigan, United States
- Ypsilanti, Michigan, United States
- Rochester, Minnesota, United States
- Albuquerque, New Mexico, United States
- New York, New York, United States
- Pittsburgh, Pennsylvania, United States
+ 128 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Little Rock, Arkansas, United States; Coronado, California, United States; Los Angeles, California, United States; Sacramento, California, United States; Aurora, Colorado, United States and 142 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.