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.
Who Can Participate?
Eligibility
Stable home TPN patients
Age Range
12-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Evenings
Compensation
Yes
Spanish Materials Available
No
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
Wischmeyer
Protocol Number
PRO00117629
Phase
II/III
Enrollment Status
Pending Open to Enrollment