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NCT01904058 · ClinicalTrials.gov registry record · Phase 2

Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis

A Phase 2 study of Primary Biliary Cirrhosis and PBC, sponsored by Mirum Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
66
Enrollment target
20
Study locations

NCT01904058 is a Phase 2 study of Primary Biliary Cirrhosis and PBC that has completed, run by Mirum Pharmaceuticals. The registered enrollment target is 66 participants, below the 1,433-participant average among 7 other Primary Biliary Cirrhosis trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 15 states.

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The verdict

NCT01904058, a Phase 2 study of Primary Biliary Cirrhosis and PBC, has completed, sponsored by Mirum Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
66 participants
Enrollment target
20
Study locations

Study Summary

The study is a randomized, double-blind, placebo-controlled, multicenter study. It is a 13-week Phase 2 study in adults with primary biliary cirrhosis designed to compare the effect of daily dosing with UDCA in combination with LUM001 or placebo.

Conditions Studied

Primary Biliary Cirrhosis PBC

Interventions

  • DRUG Placebo
  • DRUG LUM001
  • DRUG Ursodeoxycholic Acid

Study Locations (20)

California

  • Scripps Clinic - La Jolla
  • University of California at Davis - Sacramento

Minnesota

  • Mayo Clinic - Rochester
  • Minnesota Gastroenterology - Saint Paul

Texas

  • University of Texas Southwestern Medical Center - Dallas
  • Advanced Liver Therapies at St. Lukes Episcopal Hospital - Houston

Virginia

  • Liver Institute of Virginia - Newport News
  • Hunter Holmes McGuire VA Medical Center - Richmond

England

  • University of Birmingham - Birmingham
  • Royal Liverpool & Broadgreen University Hospital - Liverpool

Florida

  • University of Miami - Miami

Illinois

  • University of Chicago Medical Center - Chicago

Indiana

  • Indiana University - Indianapolis

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2013-08
Est. Completion 2015-04
Phase Phase 2

Sponsor

Mirum Pharmaceuticals

28 total trials

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What the Registry Record Tells You About NCT01904058

The ClinicalTrials.gov registry entry for NCT01904058 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,433-participant average among 7 other Primary Biliary Cirrhosis trials with a reported enrollment target (95% lower). The listed sponsor is Mirum Pharmaceuticals, which has 28 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Primary Biliary Cirrhosis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT01904058 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Minnesota, Texas.

Frequently Asked Questions

What is clinical trial NCT01904058 about?

NCT01904058 is a clinical study titled "Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis". The study is a randomized, double-blind, placebo-controlled, multicenter study. It is a 13-week Phase 2 study in adults with primary biliary cirrhosis designed to compare the effect of daily dosing with UDCA in combination with LUM001 or placebo.

What is the current status of trial NCT01904058?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2013-08. Estimated completion is 2015-04.

What conditions does trial NCT01904058 study?

This clinical trial studies the following conditions: Primary Biliary Cirrhosis, PBC.

What interventions are being tested in trial NCT01904058?

The interventions under investigation include: Placebo (DRUG), LUM001 (DRUG), Ursodeoxycholic Acid (DRUG).

Who is sponsoring clinical trial NCT01904058?

This trial is sponsored by Mirum Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01904058 being conducted?

This trial has 20 study locations across California, Florida, Illinois, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.