Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)
NCT03301506Phase 3Active, not recruiting
- Lead sponsor
- Gilead Sciences (Industry)
- Enrollment
- 340 (estimated)
- Start date
- 12 Dec 2017
- Primary completion
- Nov 2028 (estimated)
- Study completion
- 1 Dec 2028
- Last update posted
- 4 May 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Non randomized
- Intervention model
- Parallel
- Masking
- None
- Arms
- 2
Interventions
- Seladelpar 5 mg Capsule Drug
- Seladelpar 10 mg Capsule Drug
Conditions and primary outcome
- Primary Biliary Cirrhosis
Primary outcome
Treatment emergent adverse events (TEAEs) (National Cancer Institute {NCI} Common Terminology Criteria for Adverse Events {CTCAE} Version 5.0), biochemistry and hematology results (Through study completion, up to 60 Months)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
4 on PubMedLong-Term Efficacy and Safety of Selective PPARδ Agonist Seladelpar in Primary Biliary Cholangitis: ASSURE Interim Study Results.
The American journal of gastroenterology · 2025 Jun 24
PubMed 40553148 (opens in a new tab)DOI 10.14309/ajg.0000000000003603 (opens in a new tab)
Open-label, clinical trial extension: Two-year safety and efficacy results of seladelpar in patients with primary biliary cholangitis.
Alimentary pharmacology & therapeutics · 2024 Jan
PubMed 37904314 (opens in a new tab)DOI 10.1111/apt.17755 (opens in a new tab)
Novel and emerging therapies for cholestatic liver diseases.
Liver international : official journal of the International Association for the Study of the Liver · 2018 Sep
PubMed 29758112 (opens in a new tab)DOI 10.1111/liv.13880 (opens in a new tab)
Time for the dawn of multimodal therapies and the dusk for mono-therapeutic trials for cholestatic liver diseases?
Liver international : official journal of the International Association for the Study of the Liver · 2018 Jun
PubMed 29863313 (opens in a new tab)DOI 10.1111/liv.13744 (opens in a new tab)
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT03301506 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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