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Recruiting Phase 3 NCT06051617

Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis

Phase 3 – large-scale trial before approval
Conditions: Primary Biliary Cholangitis

Sponsor: Gilead Sciences

trial.available_in: БГ
Overview
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
Description
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
Who can participate
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
Locations 25
Argentina (1)
Hospital Italiano de Buenos Aires
Buenos Aires
Australia (1)
Princess Alexandra Hospital
Queensland , Queensland
Belgium (1)
UZ Antwerpen
Edegem
Canada (1)
University of Calgary
Calgary
Chile (1)
Centro de Investigación y Prevención Cardiovascular
La Serena
China (1)
Beijing Youan Hospital, Capital Medical University
Beijing
Czech Republic (1)
Fakultni nemocnice Ostrava
Ostrava
Denmark (1)
Aarhus Universitetshospital
Aarhus
France (1)
Hôpital Claude Huriez-Lille-1 Place de Verdun
Lille
Greece (1)
Evangelismos General Hospital
Athens
Hong Kong (1)
Prince of Wales Hospital - Hong Kong
Hong Kong
Hungary (1)
Semmelweis Egyetem - Sebészeti,
Budapest
Israel (1)
Lady Davis Carmel Medical Center
Haifa
Italy (1)
Azienda Ospedaliero Universitaria delle Marche -Umberto I G.M. Lancisi G. Salesi
Ancona
Mexico (1)
Clinica de Higado y Gastroenterologia Integral, S.C.
Cuernavaca
Poland (1)
ID Clinic Arkadiusz Pisula
Mysłowice
Romania (1)
Institutul Clinic Fundeni
Bucharest
Singapore (1)
National University Hospital
Singapore
South Korea (1)
Pusan National University Hospital
Busan
Spain (1)
Complexo Hospitalario Universitario De Santiago
A Coruña
Switzerland (1)
Universitätsspital Bern
Bern
Taiwan (1)
Kaohsiung Medical University Hospital
Kaohsiung City
Turkey (1)
Adana City Training and Research Hospital
Adana
United Kingdom (1)
Hull Royal Infirmary
Hull
United States (1)
St. Joseph's Hospital and Medical Center - 350 W. Thomas
Phoenix , Arizona
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
07.09.2023
Completion date
01.08.2030
Registry ID
NCT06051617
Source
anzctr
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