Status:
RECRUITING
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Lead Sponsor:
Gilead Sciences
Conditions:
Primary Biliary Cholangitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
Detailed Description
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
Eligibility Criteria
Inclusion
- Individuals must meet the following criteria to be eligible for study participation:
- Must be at least 18 years old.
- Must have a confirmed prior diagnosis of PBC
- Evidence of cirrhosis
- CP Score A or B
- 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
- 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
- Individuals must not meet any of the following criteria to be eligible for study participation:
- Prior exposure to seladelpar
- A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study
- History of liver transplantation or actively listed for cadaveric or planned living donor transplant.
- Decompensated cirrhosis
- Evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI
- Hospitalization for liver-related complication within 12 weeks of Screening
- Laboratory parameters at Screening:
- Alkaline phosphatase (ALP) \< 1.5× Upper limit of normal (ULN) or ≥ 10×ULN
- Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥5×ULN
- Total bilirubin (TB) ≥5×ULN
- Platelet count ≤50×10\^3/µL
- Albumin ≤2.8 g/dL
- Estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m\^2
- 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.
- Serum alpha-fetoprotein (AFP) \>20 ng/mL
- INR \>1.7
- CP-C cirrhosis
- History or presence of other concomitant liver diseases
Key Trial Info
Start Date :
September 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2030
Estimated Enrollment :
318 Patients enrolled
Trial Details
Trial ID
NCT06051617
Start Date
September 7 2023
End Date
August 1 2030
Last Update
December 24 2025
Active Locations (132)
Enter a location and click search to find clinical trials sorted by distance.
1
OM Research LLC
Lancaster, California, United States, 93534
2
SCPMG/Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
3
Cedar Sinai Medical Center
Los Angeles, California, United States, 90048
4
California Liver Research Institute
Pasadena, California, United States, 91105