Evaluating Seladelpar for Primary Biliary Cholangitis with Cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of Seladelpar in improving clinical outcomes for patients diagnosed with Primary Biliary Cholangitis (PBC) who also have compensated cirrhosis. Participants will receive either Seladelpar or a placebo, and their health will be monitored throughout the study. The trial aims to determine if Seladelpar can provide significant benefits in managing this chronic liver disease. Eligible participants must be at least 18 years old and have a confirmed diagnosis of PBC with evidence of cirrhosis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Individuals must meet the following criteria to be eligible for study participation:

1. Must be at least 18 years old.
2. Must have a confirmed prior diagnosis of primary biliary cholangitis (PBC)
3. Evidence of cirrhosis
4. CP Score A or B
5. Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male individuals who are sexually active with female partners of reproductive potential must use barrier contraception, and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose
6. Individuals must be able to comply with the instructions for study drug administration and be able to complete the study schedule of assessments (SOA)

Exclusion Criteria:

Individuals must not meet any of the following criteria to be eligible for study participation:

1. Prior exposure to seladelpar
2. A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study
3. History of liver transplantation or actively listed for cadaveric or planned living donor transplant.
4. Decompensated cirrhosis
5. Evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI
6. Hospitalization for liver-related complication within 12 weeks of Screening
7. Laboratory parameters at Screening:

   1. Alkaline phosphatase (ALP) \< 1.5× Upper limit of normal (ULN) or ≥ 10×ULN
   2. Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥5×ULN
   3. Total bilirubin (TB) ≤ 0.6 × ULN or ≥ 5 × ULN
   4. Platelet count ≤50×10\^3/µL
   5. Albumin ≤2.8 g/dL
   6. Estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m\^2
   7. MELD score \>12. For individuals on anticoagulation medication, baseline International normalized ratio (INR) determination for MELD score calculation should take anticoagulant use into account, in consultation with the Medical Monitor.
   8. Serum alpha-fetoprotein (AFP) \>20 ng/mL
   9. INR \>1.7
8. CP-C cirrhosis
9. History or presence of other concomitant liver diseases

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• St. Joseph's Hospital and Medical Center - 350 W. Thomas
  Phoenix, Arizona, United States Recruiting
• OM Research LLC
  Lancaster, California, United States Recruiting
• SCPMG/Kaiser Permanente Los Angeles Medical Center
  Los Angeles, California, United States Recruiting
• Cedar Sinai Medical Center
  Los Angeles, California, United States Recruiting
• California Liver Research Institute
  Pasadena, California, United States Recruiting

+168 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Gilead Clinical Study Information Center
• Email: GileadClinicalTrials@gilead.com
• Phone: 1-833-445-3230 (GILEAD-0)

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Seladelpar and Cilofexor in Primary Biliary Cholangitis (PBC)

  This study tests whether combining seladelpar with cilofexor helps people with primary biliary cholangitis more than seladelpar alone or placebo.

  Recruiting at 4 sites Phase 2 Gilead Sciences · Colorado Springs, Colorado and 3 other locations · NCT07841977

• Austrian PBC Registry

  This registry follows adults with primary biliary cholangitis in Austrian centers to see how the disease develops over time and how biomarkers relate to complications and symptoms.

  Recruiting Medical University of Vienna · Klagenfurt, Carinthia and 10 other locations · NCT07598669

• Biochemical response and health outcomes in people with primary biliary cholangitis

  We will follow adults with primary biliary cholangitis who are taking ursodeoxycholic acid (UDCA) to see if their alkaline phosphatase levels after treatment predict how long they stay free of complications.

  Recruiting RenJi Hospital · Shanghai, Shanghai Municipality · NCT07449793

• Saroglitazar Magnesium for PBC with incomplete UDCA response or intolerance

  This study tests whether Saroglitazar Magnesium can help people with primary biliary cholangitis who still have high alkaline phosphatase despite UDCA or cannot take UDCA.

  Recruiting Phase 3 Zydus Therapeutics Inc. · Lakewood Rch, Florida · NCT07424677

• CS0159 for primary biliary cholangitis when UDCA doesn't work or isn't tolerated.

  This test tries to see if taking CS0159 once daily helps adults with primary biliary cholangitis who have an inadequate response to or cannot tolerate UDCA.

  Recruiting at 39 sites Phase 3 Cascade Pharmaceuticals, Inc · Hefei, Anhui and 41 other locations · NCT07282353

• Saroglitazar Magnesium-V as add-on therapy for primary biliary cholangitis

  This trial tests whether Saroglitazar Magnesium-V, compared with placebo, can improve long-term clinical outcomes in adults with primary biliary cholangitis who are on UDCA.

  Recruiting at 3 sites Phase 3 Zydus Therapeutics Inc. · Marietta, Georgia and 2 other locations · NCT07216235

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.