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Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)

StatusActive, Not Recruiting
PhasePhase 3
Started2017-12-12
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 80 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-05-01
Study Status, Study Design, Contacts/Locations v79
Completion date2028-11→2028-12
Enrollment target500→340
Study sites108→109
2025-12-19
Study Identification, Study Status, Arms and Interventions, Eligibility, References v78
Eligibility criteria+78 characters
[...] he study and for at least 90 days after the last dose. Male subjectsindividuals who are sexually active with female partners of reproductiv [...] lusion Criteria: Exclusion criteria are only applicable for subjectsindividuals with a seladelpar interruption greater than 4 weeks prior to Day 1 of this study and for subjectsindividuals who participated in CB8025-21838 irrespective of seladelpar [...] de full participation in the study or confound its results (e.g.eg, cancer, any active infection) AST or ALT above 3 × the upp [...] al (ULN) Total bilirubin above 2 × ULN MELD score ≥ 12. For subjectsindividuals on anti [...] [...]
Study title+13 characters
Study of Seladelpar in SubjectsParticipants With Primary Biliary Cholangitis (PBC)
2025-04-15
Study Status, Contacts/Locations v77
Study sites109→108
2025-03-05
Study Status, Contacts/Locations v76
Study sitesdetails revised at 1 of 109 sites
2025-02-03
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v75
Trial statusRecruiting→Active, Not Recruiting
Study sites112→109
Show 45 earlier versions
2024-11-22
Study Status v74
Re-verified, no change to tracked fields
2024-10-14
Study Identification, Study Status, Arms and Interventions, Eligibility, Contacts/Locations, IPDSharing v73
Primary completion date2024-12→2028-11
Completion date2025-12→2028-11
Study sites118→112
Eligibility criteria+11 characters
[...] terruption. Treatment-related adverse event (AE) leading to seladelparstudy drug discontinuation in a previous PBC study with seladelpar (MBX-8025) A medical condition, other than PBC, that in the investigatorInvestigator's opinion would preclude full participation in the study or confound its results (e.g., cancer, any active infection) AST or ALT above 3 × the upper limit of normal (ULN) Total [...]
2024-06-14
Study Identification, Study Status v72
Re-verified, no change to tracked fields
2024-02-14
Study Status, Contacts/Locations v71
Study sites113→118
2023-08-28
Study Status, Contacts/Locations v70
Study sitesdetails revised at 4 of 113 sites
2023-06-15
Study Status, Contacts/Locations v69
Study sites110→113
2023-04-13
Study Status, Contacts/Locations v68
Study sites104→110
2023-03-08
Study Status, Contacts/Locations v67
Study sites96→104
2023-02-03
Study Status v66
Re-verified, no change to tracked fields
2023-01-27
Study Status, Contacts/Locations v65
Study sites93→96
2023-01-26
Study Status, Contacts/Locations v64
Study sites92→93
2022-12-20
Study Status, Contacts/Locations v63
Study sites79→92
2022-10-10
Study Status, Contacts/Locations v62
Study sites75→79
2022-09-07
Study Status, Contacts/Locations v61
Study sites74→75
2022-06-02
Study Status, Contacts/Locations v60
Study sites73→74
2022-04-29
Study Status, Contacts/Locations v59
Re-verified, no change to tracked fields
2022-03-18
Study Status, Eligibility, Contacts/Locations v58
Study sites70→73
Eligibility criteria+841 characters
[...] of normal (ULN) Total bilirubin above 2 × ULN MELD score ≥ 1512. For subjects on anticoagulation medication, evaluation of the baseline INR, in concert with any current dose adjustments in anti-coagulant medications, will be taken into account when calculating this score. This will be done in consultation with the medical monitor. Evidence of advanced PBC as defined by the Rotterdam criteri [...] mit of normal (LLN) AND total bilirubin above 1 × ULN) eGFR below 60≤45 mL/min/1.73 m2 (calculated by MDRD formula) Auto-immune hep [...] quality of the clinical study, as judged by the Investigator Immunosuppress [...]
2022-03-16
Study Status, Contacts/Locations v57
Study sites69→70
2022-02-06
Study Status, Contacts/Locations v56
Study sites68→69
2022-02-04
Study Status, Contacts/Locations v55
Study sites67→68
2022-01-25
Study Status, Contacts/Locations v54
Study sites66→67
2022-01-05
Study Status, Contacts/Locations v53
Re-verified, no change to tracked fields
2022-01-03
Study Status, Contacts/Locations v52
Study sites64→66
2021-12-14
Study Status v51
Re-verified, no change to tracked fields
2021-12-07
Study Status, Contacts/Locations v50
Study sites63→64
2021-12-06
Study Status, Contacts/Locations v49
Study sites61→63
2021-11-10
Study Status, Contacts/Locations v48
Study sites60→61
2021-11-09
Study Status, Contacts/Locations v47
Study sites55→60
2021-10-20
Study Status, Contacts/Locations v46
Study sites54→55
2021-10-13
Study Status, Contacts/Locations v45
Study sites52→54
2021-10-11
Study Status, Contacts/Locations v44
Study sites42→52
2021-09-10
Study Status, Contacts/Locations v43
Study sites41→42
2021-09-09
Study Status, Contacts/Locations v42
Study sites37→41
2021-08-10
Study Status, Contacts/Locations v41
Study sites31→37
2021-07-22
Study Status, Contacts/Locations v40
Study sites28→31
2021-07-07
Study Status, Contacts/Locations v39
Study sites26→28
2021-07-01
Study Status, Contacts/Locations v38
Study sites16→26
2021-06-18
Study Status, Contacts/Locations v37
Study sites15→16
2021-06-17
Study Status, Contacts/Locations v36
Study sites13→15
2021-06-03
Study Status, Contacts/Locations v35
Study sites11→13
2021-05-27
Study Status, Contacts/Locations v34
Study sites10→11
2021-05-10
Study Status, Contacts/Locations v33
Study sites8→10
2021-04-14
Study Status, Contacts/Locations v32
Study sites7→8
2021-03-23
Study Status, Contacts/Locations v31
Study sites6→7
2021-03-10
Study Status, Contacts/Locations v30
Study sites4→6
Gilead Sciences
107 trials monitored
See 8 trials at risk
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
Trial Details
NCT Number NCT03301506
Lead Sponsor Gilead Sciences
Conditions Primary Biliary Cirrhosis
Enrollment 340 participants
Start Date 2017-12-12
Primary Completion 2028-11 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-04