Trial Outcomes & Findings for A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC (NCT NCT04024813)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Baseline, Week 24

Results posted on

2025-01-16

Participant Flow

Study was to be conducted in 60 sites in Australia, Europe, Israel, and North America. Only 1 site in the United States enrolled. The study was terminated early and only 1 participant was enrolled in the placebo arm.

Participant milestones

Participant milestones
Measure	Placebo Participant received placebo once daily until Day 14.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participant received placebo once daily until Day 14.
Overall Study Study terminated by Sponsor	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=1 Participants Participant received placebo once daily until Day 14.
Age, Customized 65 to 84 years	1 Participants n=1 Participants
Sex: Female, Male Female	0 Participants n=1 Participants
Sex: Female, Male Male	1 Participants n=1 Participants
Region of Enrollment United States	1 Participants n=1 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: The study was terminated before the outcome measure data were collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 59

Population: The data for the participant that enrolled and received placebo was included.

TEAEs were planned to be collected up to 24 weeks. Due to the early study termination, data is reported up to Day 59.

Outcome measures

Outcome measures
Measure	Placebo n=1 Participants Participant received placebo once daily until Day 14.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	0 Participants

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: The study was terminated before the outcome measure data were collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: The study was terminated before the outcome measure data were collected.

Hepatic disease progression events is defined by the first occurrence of the following events: liver transplantation, Model for End-Stage Liver Disease (MELD) score ≥ 15, hepatic decompensation events, and hepatocellular carcinoma.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
Publication restrictions are in place

Restriction type: OTHER