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

Launched by GILEAD SCIENCES · Sep 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called seladelpar to see how it affects patients with Primary Biliary Cholangitis (PBC) who also have a liver condition known as compensated cirrhosis. The goal is to evaluate whether seladelpar can improve health outcomes for these patients. The trial is currently looking for participants aged 18 and older who have been diagnosed with PBC and show signs of cirrhosis but are otherwise stable.

To be eligible, participants need to meet certain criteria, such as having a specific score indicating the severity of their liver condition and not having had any prior exposure to seladelpar. Women who can become pregnant must use two forms of birth control during the study, and men must ensure their partners are also protected. If you join the study, you will receive the study drug and will need to attend regular check-ups to monitor your health and any effects of the medication. This trial is an important step in finding better treatments for PBC and may help improve care for many patients facing this condition.

Gender

ALL

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) ≥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