Actively Recruiting
A Study of NST-6179 in Subjects With Intestinal Failure-Associated Liver Disease (IFALD).
Led by NorthSea Therapeutics B.V. · Updated on 2025-01-07
36
Participants Needed
13
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NST-6179 in subjects with intestinal failure-associated liver disease (IFALD) receiving parenteral nutrition (PN). The study will be conducted in 2 sequential parts. Up to 36 subjects diagnosed with IFALD will be enrolled in the study, of which up to 18 subjects will be enrolled in each of the 2 parts and randomized (2:1) to receive NST-6179 (N=12/part) or matched placebo (N=6/part). Subjects in Part A will receive once daily (QD) oral administration of 800 mg (32 mL solution) NST-6179 or placebo for 4 weeks. The NST-6179 dose for Part B is planned to be 1200 mg QD for 12 weeks. Actual dose, however, will be determined during the safety review meeting.
CONDITIONS
Official Title
A Study of NST-6179 in Subjects With Intestinal Failure-Associated Liver Disease (IFALD).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 16 years or older at time of consent
- Receiving parenteral nutrition for at least 6 months
- Established diagnosis of intestinal failure-associated liver disease (IFALD) with liver enzyme elevation or total bilirubin above normal for 6 months or longer
- Stable liver disease without cirrhosis indicated by ALT and AST less than 5 times upper limit of normal
- Total bilirubin 2.5 mg/dL or less if no Gilbert's Syndrome
- Serum albumin 2.5 g/dL or higher
- International normalized ratio (INR) 1.3 or lower without anticoagulant therapy
- Platelet count 120,000/mm3 or higher
You will not qualify if you...
- Evidence of other acute or chronic liver diseases including autoimmune, viral, metabolic, or alcoholic liver disease
- Signs of compensated or decompensated liver cirrhosis such as jaundice, ascites, variceal bleeding, or hepatic encephalopathy
- Hepatic impairment or end-stage liver disease with MELD score greater than 12
- Transient elastography reading over 20.0 kPA within 3 months prior to screening
- Estimated glomerular filtration rate below 45 mL/min
- Poor nutritional status with body mass index under 17 kg/m2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Mayo Clinic Scottsdale Campus
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
University of California San Francisco Medical Center
San Francisco, California, United States, 94143
Actively Recruiting
3
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Not Yet Recruiting
4
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Actively Recruiting
5
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
6
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
7
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
8
Mayo Clinic Rochester Campus
Rochester, Minnesota, United States, 55905
Actively Recruiting
9
Mount Sinai Medical Center
New York, New York, United States, 10029
Actively Recruiting
10
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
11
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
12
Vanderbilt University School of Medicine
Nashville, Tennessee, United States, 37232
Actively Recruiting
13
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
M
Michelle Yokley
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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