Seladelpar in Primary Biliary Cholangitis and Compensated Cirrhosis

What is the Purpose of this Study?

The purpose of this study is to determine whether an experimental drug called seladelpar is effective in improving outcomes for people with primary biliary cholangitis (PBC) and compensated cirrhosis. PBC is a chronic liver disease that slowly destroys the bile ducts within the liver. Liver inflammation over a period of years may cause scarring, which leads to cirrhosis. In compensated cirrhosis, scarring has occurred, but the patient does not have symptoms of the disease. The study will compare seladelpar to placebo (inactive substance) and evaluate the participant’s changes in overall health, severity of symptoms, and progression of PBC. Procedures include physical exams, clinical evaluations, blood tests, electrocardiograms, ultrasound exams, and questionnaires.

Eligibility

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

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) ≥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

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

A Randomized Double-Blind, Placebo-Controlled, Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Cholangitis and Compensated Cirrhosis

Study Details

Disease Type/Condition

Other

Principal Investigator

Ayoub, Walid

Age Group

Adult

Phase

N/A

IRB Number

STUDY00002817

ClinicalTrials.gov ID

NCT06051617

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org