Purpose of this Study
We are doing this study to find out if an experimental drug called NST-6179 (the study drug) is a a safe and effective option for patients with intestinal failure-associated liver disease (IFALD).
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Have liver disease that is associated with intestinal failure
- Do not have liver failure
- Have been getting parenteral nutrition (through a catheter) for at least 6 months
- Have not had intestinal surgery for at least 3 months
- Do not need a feeding tube to take medicine
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get a random assignment (by chance) to get the study drug or a placebo (inactive substance with no drug in it). You will have a 2-in-3 chance of getting the study drug. The study drug and placebo are a liquid solution that you take by mouth once per day.
You will visit our clinic every 2 weeks while you are in the study. The study will last for about 10 weeks.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study
Evaluating the Safety, Tolerability, Pharmacokinetics, and
Pharmacodynamics of NST-6179 in Adult Subjects with Intestinal
Failure-Associated Liver Disease (IFALD)
Evaluating the Safety, Tolerability, Pharmacokinetics, and
Pharmacodynamics of NST-6179 in Adult Subjects with Intestinal
Failure-Associated Liver Disease (IFALD)
Principal Investigator
Maria
Segovia
Protocol Number
PRO00113188
NCT ID
NCT05919680
Phase
II
Enrollment Status
Open to Enrollment