The REPLACE Registry for Cholbam® (Cholic Acid) (NCT03115086)
A Prospective, Observational, Non-Interventional, Post-Marketing, Patient Registry to Collect Data on Routine Clinical Care in Patients Treated With Cholbam® (Cholic Acid)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama Birmingham — Birmingham, Alabama
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (24 Sites)
- University of Alabama Birmingham — Birmingham, Alabama
- Stanford School of Medicine — Palo Alto, California
- UC San Francisco — San Francisco, California
- Kidz Pediatric Multispecialty Group — Hollywood, Florida
- Nemours duPont Pediatrics Specialty Clinic — Jacksonville, Florida
- Nicklaus Children's Hospital — Miami, Florida
- Children's Healthcare of Atlanta — Atlanta, Georgia
- Children's Center For Digestive Health — Atlanta, Georgia
- The Community Health Clinic — Topeka, Indiana
- Ochsner Hospital for Children — New Orleans, Louisiana
- University of Minnesota — Minneapolis, Minnesota
- Mayo Clinic — Rochester, Minnesota
- Office of Dr. Esperanza Font-Montgomery MD — Columbia, Missouri
- Washington University at St Louis — St Louis, Missouri
- NYU Langone - NYU Grossman School of Medicine — New York, New York
- Icahn School Of Medicine at Mount Sinai — New York, New York
- Montefiore Medical Center — New York, New York
- Golisano Children's Hospital, URMC — Rochester, New York
- UNC Chapel Hill — Chapel Hill, North Carolina
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
- University of Oklahoma — Oklahoma City, Oklahoma
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- Monroe-Carell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee
- Primary Children's Hospital — Salt Lake City, Utah
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Bile Acid Synthesis Disorders clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.