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A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC

NCT04024813 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2025-01-16

Study results available
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Summary

The objectives of this study are to evaluate the effect of seladelpar treatment compared to placebo on efficacy, safety, and tolerability in patients with primary sclerosing cholangitis (PSC).

Conditions

  • Primary Sclerosing Cholangitis

Interventions

DRUG

Seladelpar

Capsule(s) administered orally once daily

DRUG

Placebo to match Seladelpar

Capsule(s) administered orally once daily

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-12
Primary Completion
2020-01-09
Completion
2020-01-09
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Poland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04024813 on ClinicalTrials.gov