RECRUITING

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

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Conditions

Primary Biliary CholangitisPrimary Biliary Cholangitis (PBC)PBC

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients 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

Quick Facts

Study Start:2023-09-07
Study Completion:2029-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06051617

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Must be at least 18 years old.
  2. 2. Must have a confirmed prior diagnosis of PBC
  3. 3. Evidence of cirrhosis
  4. 4. CP Score A or B
  5. 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 subjects 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. 6. Subjects must be able to comply with the instructions for study drug administration and be able to complete the study schedule of assessments (SOA)
  1. 1. Prior exposure to seladelpar
  2. 2. A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study
  3. 3. History of liver transplantation or actively listed for cadaveric or planned living donor transplant.
  4. 4. Decompensated cirrhosis
  5. 5. Evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI
  6. 6. Hospitalization for liver-related complication within 12 weeks of Screening
  7. 7. Laboratory parameters at Screening:
  8. 1. ALP ≥10×ULN
  9. 2. ALT or AST ≥5×ULN
  10. 3. TB ≥5×ULN
  11. 4. Platelet count ≤50×10\^3/µL
  12. 5. Albumin ≤2.8 g/dL
  13. 6. Estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m\^2
  14. 7. MELD score \>12. For subjects on anticoagulation medication, baseline INR determination for MELD score calculation should take anticoagulant use into account, in consultation with the Medical Monitor.
  15. 8. Serum alpha-fetoprotein (AFP) \>20 ng/mL
  16. 9. INR \>1.7
  17. 8. CP-C cirrhosis
  18. 9. History or presence of other concomitant liver diseases

Contacts and Locations

Study Contact

Gilead Clinical Study Information Center
CONTACT
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com

Principal Investigator

Gilead Study Director
STUDY_DIRECTOR
Gilead Sciences

Study Locations (Sites)

SCPMG/Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
United States
California Liver Research Institute
Pasadena, California, 91105
United States
University of California, Davis Medical Center
Sacramento, California, 95817
United States
California Pacific Medical Center - Sutter Pacific Medical Foundation
San Francisco, California, 94115
United States
Connie Frank Transplant Center at UCSF
San Francisco, California, 94143
United States
Covenant Metabolic Specialists, LLC
Fort Myers, Florida, 33606
United States
Florida Research Institute
Lakewood Ranch, Florida, 34211
United States
Schiff Center for Liver Diseases/University of Miami
Miami, Florida, 33136
United States
Covenant Metabolic Specialists, LLC
Sarasota, Florida, 33912
United States
Piedmont Atlanta Hospital / Piedmont Transplant Institute
Atlanta, Georgia, 30309
United States
University of Chicago Medical Center
Chicago, Illinois, 60637
United States
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, 52242
United States
University of Louisville, Clinical Trials Unit
Louisville, Kentucky, 40202
United States
University Health System - East Jefferson General Hospital Campus
New Orleans, Louisiana, 70112
United States
Mercy Medical Center
Baltimore, Maryland, 21202
United States
Gastro One
Germantown, Maryland, 38138
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Henry Ford Medical Center - Columbus
Detroit, Michigan, 48202
United States
MedStar Health Research Institute / MedStar Georgetown Transplant Institute at Fairfax
Plymouth, Minnesota, 55446
United States
Ochsner Clinic Foundation
Jefferson City, Missouri, 70121
United States
Northwell Health Center for Liver Disease and Transplantation
Manhasset, New York, 11030
United States
NYU Langone Health
New York, New York, 10016
United States
Mount Sinai
New York, New York, 10029
United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
United States
University Hosptials Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
OM Research LLC
Lancaster, Pennsylvania, 93536
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
UPMC Center for Liver Diseases
Pittsburgh, Pennsylvania, 15213
United States
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, 75203
United States
University of Texas Southwestern Medical Center, Professional Office Building One
Dallas, Texas, 75235
United States
Pinnacle Clinical Research, PLLC
San Antonio, Texas, 78229
United States
Maryview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads
Richmond, Virginia, 23226
United States
VCU Health Clinical Research Services Unit (CRSU)
Richmond, Virginia, 23249
United States
Liver Institute Northwest
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: Gilead Sciences

  • Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-07
Study Completion Date2029-07

Study Record Updates

Study Start Date2023-09-07
Study Completion Date2029-07

Terms related to this study

Keywords Provided by Researchers

  • Primary Biliary Cholangitis (PBC)
  • PBC

Additional Relevant MeSH Terms

  • Primary Biliary Cholangitis