Clinical trial NCT06051617: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Official title: AFFIRM: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Primary Biliary Cholangitis
Keywords: Primary Biliary Cholangitis (PBC)
PBC
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2023-09-25
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.

Detailed description: To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.

Eligibility criteria: 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

Primary outcomes:
measure: Event Free Survival (EFS)
timeFrame: 36 months
Secondary outcomes:
measure: Overall survival
timeFrame: 36 months
measure: Liver transplant-free survival
timeFrame: 36 months
measure: Time to hospitalization
timeFrame: 36 months
measure: Time to Event Free Survival (EFS)
timeFrame: 36 months
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: OM Research LLC
state: California
city: Los Angeles
country: United States
facility: SCPMG/Kaiser Permanente Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedar Sinai Medical Center
state: California
city: Pasadena
country: United States
facility: California Liver Research Institute
state: California
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center - Sutter Pacific Medical Foundation
state: California
city: San Francisco
country: United States
facility: Connie Frank Transplant Center at UCSF
state: California
city: Fort Myers
country: United States
facility: Covenant Metabolic Specialists, LLC
state: Florida
city: Miami
country: United States
facility: Schiff Center for Liver Diseases/University of Miami
state: Florida
city: Sarasota
country: United States
facility: Covenant Metabolic Specialists, LLC
state: Florida
city: Tampa
country: United States
facility: Florida Research Institute
state: Florida
city: Atlanta
country: United States
facility: Piedmont Atlanta Hospital / Piedmont Transplant Institute
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Iowa City
country: United States
facility: University Of Iowa Hospitals And Clinics
state: Iowa
city: Louisville
country: United States
facility: University of Louisville, Clinical Trials Unit
state: Kentucky
city: Jefferson
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: New Orleans
country: United States
facility: University Health System - East Jefferson General Hospital Campus
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Medical Center - Columbus
state: Michigan
city: Manhasset
country: United States
facility: Northwell Health Center for Liver Disease and Transplantation
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hosptials Cleveland Medical Center
state: Ohio
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Center for Liver Diseases
state: Pennsylvania
city: Cordova
country: United States
facility: Gastro One
state: Tennessee
city: Dallas
country: United States
facility: The Liver Institute at Methodist Dallas Medical Center
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center, Professional Office Building One
state: Texas
city: San Antonio
country: United States
facility: Pinnacle Clinical Research, PLLC
state: Texas
city: Fairfax
country: United States
facility: MedStar Health Research Institute / MedStar Georgetown Transplant Institute at Fairfax
state: Virginia
city: Newport News
country: United States
facility: Maryview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads
state: Virginia
city: Richmond
country: United States
facility: VCU Health Clinical Research Services Unit (CRSU)
state: Virginia
city: Seattle
country: United States
facility: Liver Institute Northwest
state: Washington
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Buenos Aires Mácula
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro de Investigación y Prevención Cardiovascular
city: Adelaide
country: Australia
facility: Flinders Medical Center
state: South Australia
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Vancouver
country: Canada
facility: GI Research Institute Foundation
city: La Serena
country: Chile
facility: Centro de Investigación y Prevención Cardiovascular
city: Santiago
country: Chile
facility: Pontificia Universidad Católica de Chile
city: Santiago
country: Chile
facility: BIOCINETIC Ltda
city: Valdivia
country: Chile
facility: Clinical Research Chile SpA - PPDS
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Adana
country: Turkey
facility: Adana City Training and Research Hospital
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
city: Gaziantep
country: Turkey
facility: Gaziantep University Medical Faculty Sahinbey Research and Practice Hospital
city: Gorukle
country: Turkey
facility: Uludag University Medical Faculty
city: Izmir
country: Turkey
facility: Ege University
city: Karabağlar
country: Turkey
facility: Katip Celebi University
city: Kocaeli
country: Turkey
facility: Kocaeli University Medical Faculty Hospital
city: Mersin
country: Turkey
facility: Mersin Universitesi Tip Fakultesi Hastanesi
city: Pendik
country: Turkey
facility: Marmara University Pendik Training and Research Hospital
city: Rize Merkez
country: Turkey
facility: Rize Recep Tayyip Erdogan University Training and Research Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: