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

Study acronym: AFFIRM
StatusRecruiting
PhasePhase 3
Started2023-09-07
View on ClinicalTrials.gov ↗

Amendment history

2026-09-16
Enrollment increased: 318 → 402 participants
Trial arms changed: 2 → 3
2026-08-07
Study Status, Contacts/Locations v42
Trial sites expanded: 205 → 211 locations
2026-07-15
Study Status, Contacts/Locations v41
Study sites203→205
2026-06-19
Study Status, Contacts/Locations v40
Trial sites expanded: 199 → 203 locations
2026-05-21
Study Status, Contacts/Locations v39
Trial sites expanded: 196 → 199 locations
2026-04-28
Study Status, Contacts/Locations v38
Trial sites expanded: 191 → 196 locations
2026-03-30
Study Status, Eligibility, Contacts/Locations v37
Trial sites expanded: 178 → 191 locations
Eligibility criteria+18 characters
[...] spartate aminotransferase (AST) ≥5×ULN Total bilirubin (TB) ≤ 0.6 × ULN or ≥ 5 × ULN Platelet count ≤50×10^3/µL Albumin ≤2.8 g/dL Estim [...]
2026-02-19
Study Status, Contacts/Locations v36
Study sites159→178
2026-01-28
Study Status, Contacts/Locations v35
Study sites132→159
2025-12-23
Study Status, Contacts/Locations v34
Study sites124→132
2025-11-25
Study Status, Contacts/Locations v33
Study sites121→124
2025-11-11
Study Status, Contacts/Locations v32
Study sites110→121
2025-10-14
Study Status, Contacts/Locations v31
Study sites97→110
2025-09-10
Study Status, Contacts/Locations v30
Study sites89→97
2025-08-21
Study Status, Contacts/Locations v29
Study sites60→89
2025-05-21
Study Status, Contacts/Locations v28
Study sites54→60
2025-04-29
Study Status, Contacts/Locations v27
Study sites52→54
2025-03-28
Study Identification, Study Status, Study Design, Eligibility, Contacts/Locations, References v26
Primary completion date2029-07→2030-08
Completion date2029-07→2030-08
Enrollment target192→318
Study sites50→52
Eligibility criteria+184 characters
Inclusion Criteria: SubjectsIndividuals must meet the following criteria to be eligible for study p [...] he study and for at least 90 days after the last dose. Male subjectsindividuals who are sexually active with female partners of reproductiv [...] ring the study and for at least 90 days after the last dose SubjectsIndividuals must be able to comply with the instructions for study drug [...] the study schedule of assessments (SOA) Exclusion Criteria: SubjectsIndividuals must not meet any of the following criteria to be eligible [...] n 12 weeks of Screening Laboratory parameters at Screening: Alkaline phosphatase (AL [...] [...]
2025-02-27
Study Status, Contacts/Locations v25
Study sitesdetails revised at 2 of 50 sites
2025-01-16
Study Status, Contacts/Locations v24
Study sites49→50
2024-12-13
3 amendments v21-v23
3 re-verifications since 2024-10-17, no change to tracked fields
2024-09-27
Study Identification, Study Status, Contacts/Locations v20
Study sites46→49
2024-08-08
Study Status, Contacts/Locations v19
Study sites40→46
2024-07-26
Study Status, Arms and Interventions, Eligibility v18
Eligibility criteria-8 characters
Inclusion Criteria: Subjects must meet the following criteria to be eligible for study participation: Must be at least 18 to 75 years old (inclusive). Must have a confirmed prior diagnosis of PBC Evidence of ci [...] ng: ALP ≥10×ULN ALT or AST ≥5×ULN TB ≥5×ULN Platelet count ≤7550×10^3/µL Albumin ≤2.8 g/dL Estimated glomerular filtration r [...]
2024-07-26
Study Status, Arms and Interventions, Outcome Measures v17
InterventionsPlacebo (Drug), Seladelpar 10 mg (Drug)→Placebo (Drug), Seladelpar (Drug)
Secondary endpointsdetails revised at 3 of 4 entries
2024-06-14
Study Status, Contacts/Locations v16
Study sites37→40
2024-05-09
Study Status, Contacts/Locations v15
Study sites32→37
2024-04-08
Study Status, Contacts/Locations v14
Study sites27→32
2024-03-19
Study Status, Contacts/Locations v13
Study sites26→27
2024-03-03
Study Status, Contacts/Locations v12
Study sites22→26
2024-02-05
Study Status, Contacts/Locations v11
Study sites20→22
2024-01-30
Study Status, Contacts/Locations v10
Study sites19→20
2024-01-23
Study Status, Contacts/Locations v9
Study sites18→19
2024-01-17
Study Status, Contacts/Locations v8
Study sites17→18
2023-12-20
Study Status, Contacts/Locations v7
Study sites14→17
2023-12-07
Study Status, Contacts/Locations v6
Study sites12→14
2023-11-22
Study Status, Contacts/Locations v5
Study sites10→12
2023-11-01
Study Status, Contacts/Locations v4
Study sites9→10
2023-10-30
Study Status, Contacts/Locations v3
Study sites8→9
2023-10-19
Study Status, Contacts/Locations v2
Study sites5→8
2023-09-26
Study Identification, Study Status, Study Description, Conditions v1
Study description+135 characters
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
Study title-108 characters
AFFIRM: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in PatientsSubjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
2023-09-18
Original filing
Gilead Sciences
107 trials monitored
See 8 trials at risk
The goal of this clinical study is to learn more about the study drug, seladelpar, and its effects on clinical outcomes in participants with primary biliary cholangitis (PBC) and compensated cirrhosis. The primary objective of this study is 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.
Trial Details
NCT Number NCT06051617
Lead Sponsor Gilead Sciences
Conditions Primary Biliary Cholangitis
Enrollment 402 participants
Start Date 2023-09-07
Primary Completion 2030-08 (estimated)
Study Completion 2030-08 (estimated)
Updated on ClinicalTrials.gov 2026-09-15