Evaluation of LUM001 in the Reduction of Pruritus in Alagille Syndrome

Completed · Phase 2 · Has a placebo group

Conditions studied: Alagille Syndrome

In brief

The study is a randomized, double-blind, placebo-controlled study in children with Alagille Syndrome (ALGS). The study will investigate the effects of LUM001, compared to placebo, on pruritus, serum bile acids, liver enzymes, and other biochemical markers in patients with ALGS.

Key facts

Study ID

NCT02057692

Run by

Mirum Pharmaceuticals, Inc.

People needed

37

Starts

2014-11-24

Expected to finish

2016-11-16

Last updated by the study team

2019-03-26

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Alagille Syndrome
• Evidence of cholestasis
• Moderate to severe pruritus
• Ability to understand and willingness to sign informed consent/assent prior to initiation of any study procedures

You may not qualify if…

• Surgical disruption of the enterohepatic circulation
• Liver transplant
• History or presence of other concomitant liver disease
• Females who are pregnant or lactating
• Known HIV infection

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• University of California at San Francisco — San Francisco, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• Baylor College of Medicine/Texas Children's Hospital — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• The Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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