Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Primary Biliary Cholangitis
Спонсор: Gilead Sciences
Налично на:
БГ
Обобщение
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
Описание
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
Кой може да участва
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
Места на провеждане
25
Argentina (1)
Hospital Italiano de Buenos Aires
Buenos Aires
Австралия (1)
Princess Alexandra Hospital
Queensland , Queensland
Белгия (1)
UZ Antwerpen
Edegem
Канада (1)
University of Calgary
Calgary
Chile (1)
Centro de Investigación y Prevención Cardiovascular
La Serena
Китай (1)
Beijing Youan Hospital, Capital Medical University
Beijing
Чехия (1)
Fakultni nemocnice Ostrava
Ostrava
Дания (1)
Aarhus Universitetshospital
Aarhus
Франция (1)
Hôpital Claude Huriez-Lille-1 Place de Verdun
Lille
Гърция (1)
Evangelismos General Hospital
Athens
Hong Kong (1)
Prince of Wales Hospital - Hong Kong
Hong Kong
Унгария (1)
Semmelweis Egyetem - Sebészeti,
Budapest
Израел (1)
Lady Davis Carmel Medical Center
Haifa
Италия (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
Полша (1)
ID Clinic Arkadiusz Pisula
Mysłowice
Румъния (1)
Institutul Clinic Fundeni
Bucharest
Сингапур (1)
National University Hospital
Singapore
Южна Корея (1)
Pusan National University Hospital
Busan
Испания (1)
Complexo Hospitalario Universitario De Santiago
A Coruña
Швейцария (1)
Universitätsspital Bern
Bern
Taiwan (1)
Kaohsiung Medical University Hospital
Kaohsiung City
Турция (1)
Adana City Training and Research Hospital
Adana
Великобритания (1)
Hull Royal Infirmary
Hull
САЩ (1)
St. Joseph's Hospital and Medical Center - 350 W. Thomas