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Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment of Cholestatic Liver Disease in Paediatric Patients With Alagille Syndrome

NCT01903460•Mirum Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

The study is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LUM001. Efficacy will be assessed by evaluating the effect of LUM001 versus placebo on the biochemical markers and pruritus associated with Alagille Syndrome.

Eligibility

Age

1 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

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

Exclusion Criteria

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

Locations (3)

Birmingham Children's Hospital

Birmingham, West Midlands, United Kingdom

Leeds Teaching Hospitals

Leeds, West Yorkshire, United Kingdom

Kings College Hospital

London, United Kingdom

Key Dates

Start Date

August 1, 2013

Primary Completion Date

February 1, 2015

Completion Date

March 1, 2015

Last Updated

March 28, 2019

Enrollment

ACTUAL participants

Conditions

Alagille Syndrome

Interventions

LUM001

DRUG

Placebo

DRUG

A Study Observing the Long-term, Effectiveness and Safety of Odevixibat (Bylvay) in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment

NCT06850038

Alagille Syndrome

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RECRUITINGPHASE3

Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome

NCT05035030

Alagille Syndrome

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RECRUITING

A Database Study of Maralixibat (TAK-625) in Participants With Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 28, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome

Inclusion Criteria

Exclusion Criteria

A Study Observing the Long-term, Effectiveness and Safety of Odevixibat (Bylvay) in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment

Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome

A Database Study of Maralixibat (TAK-625) in Participants With Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC)

A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384

Validation of the Itch Reported Outcome (ItchRO) Diaries in Pediatric Cholestatic Liver Disease

Positional Cloning of the Gene(s) Responsible for Alagille Syndrome