NCT06051617 · Gilead Sciences
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
(AFFIRM)
What this study is about
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
View original scientific description
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
Interventions
DRUG
Seladelpar
Administered orally
DRUG
Placebo
Administered orally
Primary outcome measures
Event Free Survival (EFS)
Time frame: 36 months
EFS is defined as measured by the time from start of treatment to the first occurrence of any of the following clinical events: 1. Death by any cause 2. Liver transplantation 3. MELD score ≥15 4. Ascites requiring treatment 5. Hospitalization for any of the following 1. Esophageal or gastric variceal bleeding 2. Hepatic encephalopathy 3. Spontaneous bacterial peritonitis
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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) ≤ 0.6 × ULN or ≥ 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
- CP-C cirrhosis
- History or presence of other concomitant liver diseases
Where
- Birmingham, Alabama
- Phoenix, Arizona
- Lancaster, California
- Los Angeles, California
- Pasadena, California
- Redwood City, California
- Roseville, California
- Sacramento, California
- San Francisco, California
- South San Francisco, California
- Fort Myers, Florida
- Miami, Florida
And 31 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 6, 2026 · Source of record for eligibility and locations