Northsea_Segovia (Intestinal Failure-Associated Liver Disease) - Clinical Trial

What is the 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).

What is the Condition Being Studied?

Intestinal Failure-Associated Liver Disease (IFALD)

Who Can Participate in the Study?

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

For more information about this study, contact the study team at christy.walters@duke.edu.

Age Group
Adults

What is Involved?

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.

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)
Principal Investigator
Protocol Number
IRB: PRO00113188
NCT: NCT05919680
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment