A Study of NST-6179 in Subjects With Intestinal Failure-Associated Liver Disease (IFALD).
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16+
SponsorNorthSea Therapeutics B.V.
About this trial
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.
Eligibility criteria
Qualifiers
Adult persons aged 16 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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- NST-6179 Part A
- NST-6179 Part B
- Matched Placebo
Treatment groups
36 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov