Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
a study on Primary Biliary Cholangitis Cirrhosis
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UC Davis UCSF
- Dates
- study startedcompletion around
Description
Summary
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
Official Title
AFFIRM: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Details
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
Keywords
Primary Biliary Cholangitis, Primary Biliary Cholangitis (PBC), PBC, Cholangitis, Biliary Liver Cirrhosis, Seladelpar
Eligibility
You can join if…
Open to people ages 18 years and up
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)
You CAN'T join if...
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 ≤50×103/µL
- Albumin ≤2.8 g/dL
- Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2
- 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
Locations
- University of California, Davis Medical Center
accepting new patients
Sacramento California 95817 United States - Connie Frank Transplant Center at UCSF
accepting new patients
San Francisco California 94143 United States - California Pacific Medical Center - Sutter Pacific Medical Foundation
accepting new patients
San Francisco California 94109 United States - Cedar Sinai Medical Center
accepting new patients
Los Angeles California 90048 United States - SCPMG/Kaiser Permanente Los Angeles Medical Center
accepting new patients
Los Angeles California 90027 United States - California Liver Research Institute
accepting new patients
Pasadena California 91105 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Gilead Sciences
- Links
- Gilead Clinical Trials Website
- ID
- NCT06051617
- Phase
- Phase 3 research study
- Study Type
- Interventional
- Participants
- Expecting 318 study participants
- Last Updated