CompletedPhase 2

Evaluation of LUM001 in the Reduction of Pruritus in Alagille Syndrome

United States37 participantsStarted 2014-11-24

Plain-language summary

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.

Who can participate

Age range12 Months – 18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Change From Baseline to Endpoint (Week 13/Early Termination) in Pruritus

Timeframe: Baseline, Week 13/Early Termination

Trial details

NCT IDNCT02057692

SponsorMirum Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-11-16

Results submitted2017-11-07

View on ClinicalTrials.gov More Alagille Syndrome trials