Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
161actual
Sites
115
Countries
Argentina, Belgium, Brazil +11
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-09-24 | actual | When the study began enrolling |
| Primary completion | 2023-06-01 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-12-01 | estimated | The whole study's end, after follow-up |
| First posted | 2020-08-26 | actual | When this record first appeared on the registry |
| Results posted | 2024-09-05 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-08-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Primary Biliary Cirrhosis
Interventions
- Drug: Elafibranor 80mg — also filed as Iqirvo®
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFPercentage of Participants With Response to Treatment Based on Cholestasis Response at Week 52
measured At Week 52
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-02-13 · 19.5 MB · Prot_000.pdf
Statistical Analysis Planposted 2023-05-10 · 11.7 MB · SAP_001.pdf
Publications
- PMID 41937506 — linked by the registry
- PMID 37962077 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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