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Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis

RecruitingPhase 3

Sponsor: Gilead Sciences

Conditions: Primary Biliary Cholangitis

Interventions: Seladelpar, Placebo

Countries: United States, Argentina, Australia, Austria, Belgium, Canada, Chile, China

To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 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

Locations (211)

Birmingham, Alabama, United States
Phoenix, Arizona, United States
Lancaster, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Pasadena, California, United States
Redwood City, California, United States
Sacramento, California, United States
San Francisco, California, United States
San Francisco, California, United States
South San Francisco, California, United States
Fort Myers, Florida, United States
Miami, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Iowa City, Iowa, United States
Louisville, Kentucky, United States
Jefferson, Louisiana, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Bethesda, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Rochester, Minnesota, United States
Rochester, Minnesota, United States
Manhasset, New York, United States
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