Active — Not RecruitingPhase 3

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

United States340 participantsStarted 2017-12-12

Plain-language summary

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

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Must have given written informed consent (signed and dated)
✓. Participated in a PBC study with seladelpar
✓. 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

✕. Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar
✕. 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)
✕. AST or ALT above 3 × the upper limit of normal (ULN)
✕. Total bilirubin above 2 × ULN
✕. 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.
✕. 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)
✕. eGFR ≤45 mL/min/1.73 m2 (calculated by MDRD formula)
✕. Auto-immune hepatitis

What they're measuring

Treatment emergent adverse events (TEAEs) (National Cancer Institute {NCI} Common Terminology Criteria for Adverse Events {CTCAE} Version 5.0), biochemistry and hematology results

Timeframe: Through study completion, up to 60 Months

Trial details

NCT IDNCT03301506

SponsorGilead Sciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-11

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