THRIVE-3 - Clinical Trial
What is the Purpose of this Study?
This study needs two overnight stays to give a special medicine called choline and to make sure it is safe. It also includes ten visits to the clinic over about sixteen months.
What is the Condition Being Studied?
Home TPN, choline supplementation
Who Can Participate in the Study?
Stable home TPN patients
Age Group
Adults
What is Involved?
This study is testing if a special kind of medicine called IV choline is safe and works well for people who get their nutrition through a tube at home. The study also wants to find out which amount of the medicine is best for raising choline levels in the blood to help stop or fix a shortage.
Study Details
Full Title
A Phase 2b/3 Randomized Open-Label Dose-Selection Study with Open-Label Extension and Randomized Double-Blind, Placebo-Controlled Study with Open-Label Extension to Evaluate the Safety and Efficacy of Choline Chloride for Injection (Low Dose and High Dose) Versus Placebo in Adolescents and Adults with Intestinal Failure Receiving Long-Term Parenteral Support
Principal Investigator
Paul E. Wischmeyer, MD
Anesthesiologist
Protocol Number
IRB:
PRO00117629
Phase
Phase II/III
Enrollment Status
Open for Enrollment