A Study of NST-6179 in Subjects With Intestinal Failure-Associated Liver Disease (IFALD).
NCT ID: NCT05919680
Last Updated: 2025-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
36 participants
INTERVENTIONAL
2024-01-15
2025-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Part A-800 mg NST-6179
up to 12 subjects
NST-6179 Part A
Once daily (QD) oral administration of 800mg (32 mL solution) of NST-6179 for 4 weeks
Part A matched NST-6179 placebo
up to 6 subjects
Matched Placebo
Matched placebo for administration in Part A or Part B
Part B- 1200mg NST-6179
up to 12 subjects
NST-6179 Part B
Once daily (QD) oral administration of 1200mg of NST-6179 for 12 weeks
Part B matched NST-6179 placebo
up to 6 subjects
Matched Placebo
Matched placebo for administration in Part A or Part B
Interventions
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NST-6179 Part A
Once daily (QD) oral administration of 800mg (32 mL solution) of NST-6179 for 4 weeks
NST-6179 Part B
Once daily (QD) oral administration of 1200mg of NST-6179 for 12 weeks
Matched Placebo
Matched placebo for administration in Part A or Part B
Eligibility Criteria
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Inclusion Criteria
* Minimum of 6 months on Parenteral supplementation.
* Established clinical diagnosis of IFALD based on a persistent elevation of
1. liver enzymes (ALP, AST, ALT, or GGT ≥1.5 × upper limit of normal \[ULN\]) for ≥6 months and/or
2. total bilirubin \> ULN for ≥6 months.
* Laboratory parameters consistent with stable liver disease without cirrhosis as defined by:
1. ALT and AST \<5 × ULN;
2. Total bilirubin ≤2.5 mg/dL in the absence of Gilbert's Syndrome.
3. Serum albumin ≥2.5 g/dL;
4. International normalized ratio (INR) ≤1.3 in the absence of anticoagulant therapy;
5. Platelet count ≥120,000/mm3.
Exclusion Criteria
* Clinical evidence of compensated or decompensated hepatic cirrhosis as assessed by historical liver histology, ultrasound-based and/or signs and symptoms of hepatic decompensation (including, but not limited to, jaundice, ascites, variceal hemorrhage, and/or hepatic encephalopathy).
* Presence of hepatic impairment, end-stage liver disease, and/or a model for end-stage liver disease (MELD) score \>12.
* Transient elastography read \>20.0 kPA within 3 months prior to or during the Screening Period.
* Estimated glomerular filtration rate \<45 mL/min based on the 2021 CKD-EPI creatinine equation.
* Poor nutritional status defined as body mass index (BMI) \<17 kg/m2.
16 Years
ALL
No
Sponsors
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NorthSea Therapeutics B.V.
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic Scottsdale Campus
Scottsdale, Arizona, United States
University of California San Francisco Medical Center
San Francisco, California, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Emory University School of Medicine
Atlanta, Georgia, United States
The University of Chicago Medical Center
Chicago, Illinois, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mayo Clinic Rochester Campus
Rochester, Minnesota, United States
Mount Sinai Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
The Cleveland Clinic
Cleveland, Ohio, United States
Vanderbilt University School of Medicine
Nashville, Tennessee, United States
University of Washington
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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John DiBaise, MD
Role: primary
Kendall Beck, MD
Role: primary
Sukanya Subramanian
Role: primary
Thomas Ziegler, MD
Role: primary
Carol Semrad, MD
Role: primary
Mark Puder, MD
Role: primary
Syed-Mohammed Jafri, MD
Role: primary
Manpreet Mundi, MD
Role: primary
Kishore Iyer, MD
Role: primary
Maria Segovia, MD
Role: primary
Don Kirby, MD
Role: primary
Dawn Adams
Role: primary
Lei Yu, MD
Role: primary
Other Identifiers
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NST-6179-02
Identifier Type: -
Identifier Source: org_study_id
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