Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 265 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2020-02-16 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03602560
The ClinicalTrials.gov registry entry for NCT03602560 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 265 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 173-participant average among 8 other Primary Biliary Cholangitis trials with a reported enrollment target (53% higher). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.
-
Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
RECRUITING · Phase 3
-
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
RECRUITING · Phase 3
-
A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.
ACTIVE NOT RECRUITING · Phase 3
-
Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC)
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
RECRUITING · Phase 2
-
A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment
RECRUITING
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.