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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
EU CTIS ID: 2024-516525-31-01
What this study is testing
Efficacy: To evaluate the effect of seladelpar compared to placebo on EFS. EFS is defined as the time from start of treatment to the first occurrence of any of the following adjudicated events up to Week 156: Death by any cause Liver Transplantation MELD Score ≥ 15 Ascites Requiring Treatment Hospitalization for any of the following qualifying events: Esophageal or gastric variceal bleeding. Hepatic encephalopathy. Spontaneous bacterial peritonitis confirmed by WBC count, differential, and/or positive growth from aerobic and/or anaerobic blood culture bottles via diagnostic paracentesis. Safety: To evaluate the safety of seladelpar over 156 weeks of treatment compared with placebo.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Must be at least 18 years old.
- Must have a confirmed prior diagnosis of PBC
- Evidence of cirrhosis
- CP class A or B
- 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)
You likely can't join if
- 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
See the full eligibility criteria
- Must be at least 18 years old.
- Must have a confirmed prior diagnosis of PBC
- Evidence of cirrhosis
- CP class A or B
- 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)
- 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 during screening: a. ALP < 1.5× ULN b. TB ≤0.6×ULN or ≥5×ULN c. TB ≥ 5× ULN d. Platelet count ≤ 50×103/μL e. Albumin ≤ 2.8 g/dL f. Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2 g. MELD score > 12. For subjects on anticoagulation medication, baseline INR determination for MELD score calculation should take anticoagulant use into account, h. Serum alpha-fetoprotein (AFP) > 20 ng/mL i. INR > 1.7
- CP-C cirrhosis
- History or presence of other concomitant liver diseases
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Argentina
- Australia
- Switzerland
- Chile
- Turkey
- Mexico
- United Kingdom
- Korea, Republic of
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Argentina; Australia; Switzerland; Chile; Turkey and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.