Last updated 22 days ago
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
318 patients around the world
Available in Chile, Argentina, United States
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary
Biliary Cholangitis (PBC) and Compensated Cirrhosis.
Gilead Sciences
5Research sites
318Patients around the world
This study is for people with
Cholangitis
Primary biliary cholangitis
Cirrhosis
Compensated cirrhosis
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Individuals must be at least 18 years old.Individuals must have a confirmed prior diagnosis of PBC.Individuals must have evidence of cirrhosis.Individuals must have a 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.
- Individuals must not have prior exposure to seladelpar.Individuals must not have a medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study.Individuals must not have a history of liver transplantation or actively listed for cadaveric or planned living donor transplant.Individuals must not have decompensated cirrhosis.Individuals must not have evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI.Individuals must not have been hospitalized for a liver-related complication within 12 weeks of Screening.Individuals must not have laboratory parameters at Screening:Alkaline phosphatase (ALP) < 1.5× Upper limit of normal (ULN) or ≥ 10×ULN.Individuals must not have laboratory parameters at Screening: Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥5×ULN.Individuals must not have laboratory parameters at Screening: Total bilirubin (TB) ≥5×ULN.Individuals must not have laboratory parameters at Screening: Platelet count ≤50×10^3/µL.Individuals must not have laboratory parameters at Screening: Albumin ≤2.8 g/dL.Individuals must not have laboratory parameters at Screening: Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m^2.Individuals must not have laboratory parameters at Screening: 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.Individuals must not have laboratory parameters at Screening: INR >1.7.Individuals must not have CP-C cirrhosis.Individuals must not have a history or presence of other concomitant liver diseases.
Sites
CIPREC Centro de Investigación y Prevención Cardiovascular - CABA
Recruiting
Buenos Aires Mácula S.A.
Recruiting
Clinical Research Chile SpA
Recruiting
Hospital Clínico Pontificia Universidad Católica de Chile - Santiago, Región Metropolitana
Recruiting
BIOCINETIC SpA
Recruiting
StudyAFFIRM
SponsorGilead Sciences
Study typeInterventional
Conditions
Primary biliary cholangitisCompensated cirrhosis
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06051617
