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Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

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

ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)

NCT03301506•Gilead Sciences

View on ClinicalTrials.gov

Summary

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)

Detailed Description

Primary: To evaluate the long-term safety and tolerability of seladelpar Secondary: * To evaluate the long-term efficacy of seladelpar * To evaluate the effect of seladelpar on patient-reported outcomes (pruritus)

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Must have given written informed consent (signed and dated)
•2. Participated in a PBC study with seladelpar
•3. Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male individuals 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

Exclusion Criteria

•1. Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar
•2. A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results (eg, cancer, any active infection)
•3. AST or ALT above 3 × the upper limit of normal (ULN)
•4. Total bilirubin above 2 × ULN
•5. MELD score ≥ 12. For individuals 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.
•6. Evidence of advanced PBC as defined by the Rotterdam criteria: albumin below 1× the lower limit of normal (LLN) AND total bilirubin above 1 × ULN)
•7. eGFR ≤45 mL/min/1.73 m2 (calculated by MDRD formula)
•8. Auto-immune hepatitis
•9. Primary sclerosing cholangitis
•10. Known history of alpha-1-antitrypsin deficiency
+16 more criteria

Locations (108)

Arkansas Diagnostic Center

Little Rock, Arkansas, United States

Stanford University School of Medicine

Palo Alto, California, United States

California Liver Research Institute

Pasadena, California, United States

University of California Davis Medical Center

Sacramento, California, United States

California Pacific Medical Center

San Francisco, California, United States

University of Colorado - Denver - PPDS

Aurora, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Covenant Research Fort Myers

Fort Myers, Florida, United States

Florida Digestive Health Specialist

Lakewood Rch, Florida, United States

University of Miami Miller School of Medicine

Miami, Florida, United States

Key Dates

Start Date

December 12, 2017

Primary Completion Date

November 1, 2028

Completion Date

November 1, 2028

Last Updated

December 23, 2025

Enrollment

500

ESTIMATED participants

Conditions

Primary Biliary Cirrhosis

Interventions

Seladelpar 5 mg Capsule

DRUG

Seladelpar 10 mg Capsule

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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