A Study of NST-6179 in Adult Subjects With Intestinal Failure-Associated Liver Disease (IFALD).
Intestinal Failure Associated Liver Disease
About this trial
This is an interventional treatment trial for Intestinal Failure Associated Liver Disease
Eligibility Criteria
Key Inclusion Criteria: Adult persons aged 18 years or older at the time of informed consent. Minimum of 6 months on Parenteral supplementation. Established clinical diagnosis of IFALD based on a persistent elevation of liver enzymes (ALP, AST, ALT, or GGT ≥1.5 × upper limit of normal [ULN]) for ≥6 months and/or total bilirubin > ULN for ≥6 months. Laboratory parameters consistent with stable liver disease without cirrhosis as defined by: ALT and AST <5 × ULN; Total bilirubin ≤2.0 mg/dL in the absence of Gilbert's Syndrome. Serum albumin ≥3 g/dL; International normalized ratio (INR) ≤1.3 in the absence of anticoagulant therapy; Platelet count ≥120,000/mm3. Key Exclusion Criteria: Clinical, laboratory, imaging, or histopathologic evidence of other causes of acute or chronic liver disease, including autoimmune, viral, metabolic, or alcoholic liver disease. 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Part A-800 mg NST-6179
Part A matched NST-6179 placebo
Part B- 1200mg NST-6179
Part B matched NST-6179 placebo
up to 12 subjects
up to 6 subjects
up to 12 subjects
up to 6 subjects