Evaluation of LUM001 in the Reduction of Pruritus in Alagille Syndrome
NCT ID: NCT02057692
Last Updated: 2019-03-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
37 participants
INTERVENTIONAL
2014-11-24
2016-11-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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LUM001
LUM001 for oral administration
LUM001
LUM001 administered orally
Placebo
Placebo administered orally once each day
Placebo
Placebo administered orally
Interventions
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LUM001
LUM001 administered orally
Placebo
Placebo administered orally
Eligibility Criteria
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Inclusion Criteria
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
2. Liver transplant
3. History or presence of other concomitant liver disease
4. Females who are pregnant or lactating
5. Known HIV infection
12 Months
18 Years
ALL
No
Sponsors
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Childhood Liver Disease Research and Education Network
OTHER
Mirum Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Mirum
Locations
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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
Countries
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Other Identifiers
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LUM001-301
Identifier Type: -
Identifier Source: org_study_id
NCT02055768
Identifier Type: -
Identifier Source: nct_alias
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