Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
55 participants
OBSERVATIONAL
2017-07-10
2039-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Existing User
Patients who have been using Cholbam for at least 30 days
Cholbam
Cholbam prescribed according to the approved label.
New User
First-time initiators of Cholbam
Cholbam
Cholbam prescribed according to the approved label.
Interventions
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Cholbam
Cholbam prescribed according to the approved label.
Eligibility Criteria
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Inclusion Criteria
2. The patient and/or the patient's parent/legal guardian is willing and able to provide signed informed consent, and the patient, if less than 18 years of age, is willing to provide assent as appropriate and in accordance with local regulatory, IRB, and EC requirements.
3. The patient has a diagnosis for which Cholbam is indicated.
4. The patient is or will be treated with Cholbam at the time of signing the informed consent form (ICF) (enrollment).
Exclusion Criteria
ALL
No
Sponsors
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Mirum Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sagar A Vaidya, MD, PhD
Role: STUDY_DIRECTOR
Vice President, Clinical Development
Locations
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University of Alabama Birmingham
Birmingham, Alabama, United States
Stanford School of Medicine
Palo Alto, California, United States
UC San Francisco
San Francisco, California, United States
Kidz Pediatric Multispecialty Group
Hollywood, Florida, United States
Nemours duPont Pediatrics Specialty Clinic
Jacksonville, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Children's Center For Digestive Health
Atlanta, Georgia, United States
The Community Health Clinic
Topeka, Indiana, United States
Ochsner Hospital for Children
New Orleans, Louisiana, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Office of Dr. Esperanza Font-Montgomery MD
Columbia, Missouri, United States
Washington University at St Louis
St Louis, Missouri, United States
Icahn School Of Medicine at Mount Sinai
New York, New York, United States
Montefiore Medical Center
New York, New York, United States
Golisano Children's Hospital, URMC
Rochester, New York, United States
UNC Chapel Hill
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Monroe-Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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031CHO15001
Identifier Type: -
Identifier Source: org_study_id
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