Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Purpose
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
Condition
- Primary Biliary Cholangitis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Seladelpar |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
Birmingham, Alabama 35233
Phoenix, Arizona 85013
Lancaster, California 93534
Los Angeles, California 90027
Los Angeles, California 90048
Pasadena, California 91105
Redwood City, California 94063
Sacramento, California 95817
San Francisco, California 94109
San Francisco, California 94143
South San Francisco, California 94080
Fort Myers, Florida 33912
Miami, Florida 33136
Sarasota, Florida 33912
Tampa, Florida 34211
Atlanta, Georgia 30309
Chicago, Illinois 60611
Chicago, Illinois 60637
Iowa City, Iowa 52242
Louisville, Kentucky 40202
Jefferson, Louisiana 70121
New Orleans, Louisiana 70112
Baltimore, Maryland 21202
Bethesda, Maryland 20889
Boston, Massachusetts 02114
Boston, Massachusetts 02215
Detroit, Michigan 48202
Rochester, Minnesota 14642
Rochester, Minnesota 55905
Manhasset, New York 11030
New York, New York 10016
New York, New York 10021
New York, New York 10029
Winston-Salem, North Carolina 27157
Cleveland, Ohio 44106
Cleveland, Ohio 44195
Columbus, Ohio 43210
Hershey, Pennsylvania 17033
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19107
Pittsburgh, Pennsylvania 15213
Charleston, South Carolina 29425
Cordova, Tennessee 38018
Dallas, Texas 75203
Dallas, Texas 75390
Denison, Texas 75020
San Antonio, Texas 78215
San Antonio, Texas 78229
Fairfax, Virginia 22031
Newport News, Virginia 23602
Richmond, Virginia 23298
Seattle, Washington 98105
Manati, Puerto Rico 00674
More Details
- Status
- Recruiting
- Sponsor
- Gilead Sciences
Study Contact
Gilead Clinical Study Information Center1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com
Detailed Description
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.