Trial Summary
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
Status
Recruiting
Condition
Primary Biliary Cholangitis
Actual Start Date
September 07, 2023
Estimated Primary Completion Date
July 2029
About the Trial
The AFFIRM trial is designed to characterize the efficacy and safety of seladelpar in a PBC population with advanced disease and to confirm its benefit on longer-term clinical outcomes. The AFFIRM trial is planned to enroll approximately 192 patients with PBC who have compensated cirrhosis (Child-Pugh A or Child-Pugh B). Patients will be randomly assigned using a 2:1 ratio to oral, once daily seladelpar or placebo for three years. Hence, the AFFIRM trial will aim to confirm the benefit of seladelpar in patients with advanced PBC over a three year period.
Detailed Info
Brief Summary
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
ClinicalTrials.gov ID
NCT06051617
Study Phase
Phase 3
Estimated Enrollment
192
Estimated Primary Completion Date
July 2029
Study Type
Interventional
Interventions
- DRUG: Seladelpar 10 mg
- Seladelpar 10 mg one capsule daily for up to 36 months.
- DRUG: Placebo
- One capsule daily for up to 36 months.
Sponsor
CymaBay Therapeutics, Inc.
Eligibility
Inclusion Criteria
Qualities or factors you must have to be included in the trial. The trial site may advise you on additional factors.
Gender
All
Age
18 Years to 75 Years (Adult, Older Adult )
Child-Pugh score
A or B
- Must have a confirmed prior diagnosis of PBC
- Evidence of cirrhosis
- 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
- 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
Qualities or factors that would not allow you to participate in the trial. The trial site may advise you on additional factors.
- Prior exposure to seladelpar
- A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study
- History of liver transplantation or actively listed for cadaveric or planned living donor transplant.
- Decompensated cirrhosis
- Evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI
- Hospitalization for liver-related complication within 12 weeks of Screening
- Laboratory parameters at Screening:
- ALP ≥10×ULN
- ALT or AST ≥5×ULN
- TB ≥5×ULN
- Platelet count ≤75×10^3/µL
- Albumin ≤2.8 g/dL
- Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m^2
- 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.
- Serum alpha-fetoprotein (AFP) >20 ng/mL
- INR >1.7
- CP-C cirrhosis
- History or presence of other concomitant liver diseases
Locations
The following cities have Seladelpar clinical trial sites. Please check back often as locations will be updated.
Enrollment
For more information on enrollment into our current clinical trials, please contact us or visit clinicaltrials.gov for location information.
About Primary Biliary Cholangitis (PBC)?
PBC is a rare, chronic, autoimmune liver disease that progressively destroys the liver’s bile ducts.
Read More About PBCFrequently Asked Questions
What is a clinical trial?
A Clinical Trial is a type of research study that examines how well a potential therapy works in humans.
Why is this trial being done?
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
How do I know if I can participate in this trial?
This clinical trial has certain criteria that a person has to meet to determine if they can participate. After you have discussed the trial with your doctor, specific tests will be done to see if you qualify for this study.
Who is sponsoring this trial?
CymaBay Therapeutics, Inc. is sponsoring this clinical trial.
How many people will participate in this trial?
There will be a total of 192 patients enrolled in this clinical trial.
Where do I go to participate in this clinical trial?
After you have discussed the trial with your doctor, contact CymaBay Therapeutics, Inc. to coordinate with the study site closest to where you live.
The safety and efficacy of the investigational use of this product has not been determined. There is no guarantee that the investigational use listed will be filed with and/or approved for marketing by a regulatory agency.