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NCT03602560 · ClinicalTrials.gov registry record · Phase 3

ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

A Phase 3 study of Primary Biliary Cholangitis, sponsored by Gilead Sciences.

Completed
Registry status
Phase 3
Development phase
265
Enrollment target
20
Study locations

NCT03602560: Completed Phase 3 study of Primary Biliary Cholangitis, sponsored by Gilead Sciences.

NCT03602560 is a Phase 3 study of Primary Biliary Cholangitis that has completed, run by Gilead Sciences. The registered enrollment target is 265 participants, above the 173-participant average among 8 other Primary Biliary Cholangitis trials with a reported enrollment target (53% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03602560, a Phase 3 study of Primary Biliary Cholangitis, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 3
Development phase
265 participants
Enrollment target
20
Study locations

Study Summary

A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) The participants might enter the ongoing open-label safety study (NCT03301506) following this double-blind study.

Primary Outcome

Percentage of Participants with Response to Composite Endpoint of ALP \<1.67 × Upper Limit of Normal \[ULN\], ≥15% reduction in ALP, and total bilirubin ≤ ULN) at Month 3. The mITT analysis set included all randomized subjects who received at least one study drug dose. The primary endpoint was analyzed using Cochran-Mantel-Haenszel (CMH) test adjusted for both randomization stratification variables (ALP level: \<350 U/L and 2:350 U/L; pruritus NRS: \<4 and 2:4). The CMH tests were performed for

Conditions Studied

Primary Biliary Cholangitis

Interventions

  • DRUG Placebo
  • DRUG seladelpar 5-10 mg
  • DRUG seladelpar 10 mg

Study Locations (20)

California

  • Cedars Sinai Medical Center - Los Angeles
  • Stanford University School of Medicine - Redwood City
  • University of California Davis Medical Center - Sacramento
  • California Pacific Medical Center - San Francisco

Florida

  • Excel Medical Clinical Trials, LLC - Boca Raton
  • Florida Reserach Institute - Lakewood Rch
  • Schiff Center for Liver Diseases University of Miami - Miami
  • Tampa General Medical Group - Tampa

Arizona

  • Institute for Liver Health - Chandler
  • Mayo Clinic Arizona - PPDS - Phoenix
  • The Institute for Liver Health-Tucson - Tucson

Massachusetts

  • Beth Israel Deaconess Medical Center - Boston
  • Massachusetts General Hospital - Boston

Colorado

  • Univeristy of Colorado Denver and Hospital - Aurora

Connecticut

  • Yale School of Medicine Digestive Diseases, Internal Medicine - New Haven

Georgia

  • Digestive Healthcare of Georgia - Atlanta

Illinois

  • University of Chicago Medical Center - Chicago

Trial Details

FieldValue
Enrollment Target 265 participants
Start Date 2018-10-01
Est. Completion 2020-02-16
Phase Phase 3
Gilead Sciences

504 total trials

What the finished NCT03602560 record still lists

NCT03602560 is an interventional study that assigns participants to a tested intervention. The registered 265 participants enrollment target is mid-sized for trials with a published cap, above the 173-participant average among 8 other Primary Biliary Cholangitis trials with a reported enrollment target (53% higher).

The record links to 1 condition, with Primary Biliary Cholangitis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT03602560 names 20 study sites across 11 states, led by California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT03602560 about?

NCT03602560 is a clinical study titled "ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)". A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) The participants might enter the ongoing open-label safety study ...

What is the current status of trial NCT03602560?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 265 participants. The study started on 2018-10-01. Estimated completion is 2020-02-16.

What conditions does trial NCT03602560 study?

This clinical trial studies the following conditions: Primary Biliary Cholangitis.

What interventions are being tested in trial NCT03602560?

The interventions under investigation include: Placebo (DRUG), seladelpar 5-10 mg (DRUG), seladelpar 10 mg (DRUG).

Who is sponsoring clinical trial NCT03602560?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03602560 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Primary Biliary Cholangitis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03602560's enrollment target sits among peer trials

265 3rd of 8 higher than 6 of 8 other Primary Biliary Cholangitis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Primary Biliary Cholangitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03602560, the US trial registry maintained by the National Library of Medicine. NCT03602560 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.