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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06051617
Other study ID # CB8025-41837
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date September 7, 2023
Est. completion date July 2029

Study information

Verified date April 2024
Source CymaBay Therapeutics, Inc.
Contact Barry Crittenden, MD
Phone 510-293-8800
Email medinfo@cymabay.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 192
Est. completion date July 2029
Est. primary completion date July 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: Subjects must meet the following criteria to be eligible for study participation: 1. Must be 18 to 75 years old (inclusive) 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 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. Subjects 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: Subjects 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. ALP =10×ULN 2. ALT or AST =5×ULN 3. TB =5×ULN 4. Platelet count =75×10^3/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 subjects on anticoagulation medication, baseline 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

Study Design


Intervention

Drug:
Seladelpar 10 mg
Seladelpar 10 mg one capsule daily for up to 36 months.
Placebo
One capsule daily for up to 36 months.

Locations

Country Name City State
Korea, Republic of Pusan National University Hospital Busan
Korea, Republic of Kyungpook National University Hospital Daegu
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do
Turkey Uludag University Medical Faculty Gorkule Kampusu Bursa
Turkey Marmara University Pendik Training and Research Hospital Istanbul
Turkey Ege University, Department of Gastroenterology Izmir
Turkey Kocaeli University Medical Faculty Hospital Kocaeli
Turkey Mersin Universitesi Tip Fakultesi Hastanesi Mersin Yenisehir
Turkey Rize Recep Tayyip Erdogan University Training and Research Hospital Rize
United States Piedmont Atlanta Hospital/Piedmont Transplant Institute Atlanta Georgia
United States Mercy Medical Center Baltimore Maryland
United States Beth Israel Deconess Medical Center Boston Massachusetts
United States University of Chicago Medical Center Chicago Illinois
United States University Hospitals Cleveland Medical Center Cleveland Ohio
United States The Liver Institute at Methodist Dallas Medical Center Dallas Texas
United States University of Texas Southwestern Medical Center, Professional Office Building One Dallas Texas
United States Medstar Health Research Institute/MedStar Georgetown Transplant Fairfax Virginia
United States Covenant Metabolic Specialists, LLC Fort Myers Florida
United States University of Iowa Hospitals & Clinics Iowa City Iowa
United States Florida Research Institute, LLC Lakewood Ranch Florida
United States Om Research LLC Lancaster California
United States SCPMG/ Kaise Permanente Los Angeles Medical Center Los Angeles California
United States University of Louisville Louisville Kentucky
United States Northwell Health Center for Liver Disease and Transplantation Manhasset New York
United States University Healthcare System East Jefferson General Hospital Campus Metairie Louisiana
United States University of Miami Hospital Miami Florida
United States Ochsner Clinic Foundation New Orleans Louisiana
United States Mount Sinai New York New York
United States NYU Langone Health New York New York
United States Mayview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads Newport News Virginia
United States California Liver Research Center Pasadena California
United States UPMC Center for Liver Diseases Pittsburgh Pennsylvania
United States VCU Health Clinical Research Services Unit (CRSU) Richmond Virginia
United States University of California, Davis Medical Center (Study Visits) Sacramento California
United States Pinnacle Clinical Research, LLC San Antonio Texas
United States California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco California
United States Connie Frank Transplant center at UCSF San Francisco California
United States Covenant Metabolic Specialists, LLC Sarasota Florida
United States Liver Institute Northwest Seattle Washington
United States Wake Forest Baptist Medical Center Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
CymaBay Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Korea, Republic of,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Event Free Survival (EFS) EFS as measured by the time from start of treatment to the first occurrence of any of the following clinical events:
Death by any cause;
Liver transplantation;
MELD score =15;
Ascites requiring treatment;
Hospitalization for esophagus or stomach varices
36 months
Secondary Overall survival Time from start of treatment to death from any cause. 36 months
Secondary Liver transplant-free survival Time from start of treatment to the first occurrence of liver-related death or liver liver transplantation. 36 months
Secondary Time to hospitalization Time from start of treatment for esophagus or stomach varices 36 months
Secondary Time to Event Free Survival (EFS) MELD score =15
Ascites requiring treatment
progression to Child-Pugh-C (advanced hepatic dysfunction)
36 months
See also
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