NCT06051617 Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
| NCT ID | NCT06051617 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Gilead Sciences |
| Condition | Primary Biliary Cholangitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 318 participants |
| Start Date | 2023-09-07 |
| Primary Completion | 2030-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 318 participants in total. It began in 2023-09-07 with a primary completion date of 2030-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
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) ≤ 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
Contact & Investigator
Gilead Clinical Study Information Center
✉ GileadClinicalTrials@gilead.com📞 1-833-445-3230 (GILEAD-0)
Gilead Study Director
STUDY DIRECTOR
Gilead Sciences
Frequently Asked Questions
Who can join the NCT06051617 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Primary Biliary Cholangitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06051617 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 318 participants.
Is NCT06051617 currently recruiting?
Yes, NCT06051617 is actively recruiting participants. Contact the research team at GileadClinicalTrials@gilead.com for enrollment information.
Where is the NCT06051617 trial being conducted?
This trial is being conducted at Birmingham, United States, Phoenix, United States, Lancaster, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT06051617 clinical trial?
NCT06051617 is sponsored by Gilead Sciences. The principal investigator is Gilead Study Director at Gilead Sciences. The trial plans to enroll 318 participants.