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The REPLACE Registry for Cholbam® (Cholic Acid)
Sponsor: Mirum Pharmaceuticals, Inc.
Summary
This is a prospective, observational, non-interventional patient registry study designed to document product safety and effectiveness outcomes for 10 years in patients treated with Cholbam, including those who have been using Cholbam for at least 30 days (existing users) and those who are first-time initiators of Cholbam.
Official title: A Prospective, Observational, Non-Interventional, Post-Marketing, Patient Registry to Collect Data on Routine Clinical Care in Patients Treated With Cholbam® (Cholic Acid)
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
55
Start Date
2017-07-10
Completion Date
2039-07
Last Updated
2023-10-02
Healthy Volunteers
No
Conditions
Interventions
Cholbam
Cholbam prescribed according to the approved label.
Locations (23)
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