Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
Study details:
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- 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
- 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: 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
- CP-C cirrhosis
- History or presence of other concomitant liver diseases
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE3
Study ID
NCT06051617
Intervention or treatment
DRUG: Seladelpar
DRUG: Placebo
Conditions
- Primary Biliary Cholangitis
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Research sites nearby
Closest Location:
Princess Alexandra Hospital
Select from list below to view details:
Princess Alexandra Hospital
Queensland, Queensland, Australia
Flinders Medical Center
Adelaide, South Australia, Australia
Monash Health, Monash Medical Centre
Clayton, Victoria, Australia
Northern Health
Epping, Victoria, Australia
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Who is running the clinical trial?
Gilead Sciences
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Seladelpar
| Drug: Seladelpar |
PLACEBO_COMPARATOR: Placebo
| Drug: Placebo |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Event Free Survival (EFS) | EFS 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 | 36 months |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Time from start of treatment to death from any cause. | 36 months |
| Liver transplant-free survival | Time from start of treatment to the first occurrence of liver-related death or liver transplantation. | 36 months |
| Time to hospitalization | Time from start of treatment to the first occurrence of hospitalization for qualifying PBC clinical events | 36 months |
| Time to Event Free Survival (EFS) | 1. MELD score ≥15 2. Ascites requiring treatment | 36 months |
References
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