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

NCT03301506 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2026-05-04

No results posted yet for this study

Summary

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

Conditions

  • Primary Biliary Cirrhosis

Interventions

DRUG

Seladelpar 5 mg Capsule

Participants will be assigned to a treatment group if tolerability issues noted in the previous study.

DRUG

Seladelpar 10 mg Capsule

Participants will be assigned to a treatment group unless there are tolerability issues.

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-12
Primary Completion
2028-11-30
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Canada
  • Chile
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • New Zealand
  • Poland
  • Romania
  • Russia
  • South Korea
  • Spain
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

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 NCT03301506 on ClinicalTrials.gov