Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

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 adult subjects with intestinal failure-associated liver disease (IFALD) receiving parenteral nutrition (PN). The study will be conducted in 2 sequential parts. Up to 36 adult subjects diagnosed with IFALD will be enrolled in the study, of which 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.

Official 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)

Keywords

Intestinal Failure Associated Liver Disease, Liver Diseases, Intestinal Failure, NST-6179 Part A, NST-6179 Part B

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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
    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 ≤2.0 mg/dL in the absence of Gilbert's Syndrome.
    3. Serum albumin ≥3 g/dL;
    4. International normalized ratio (INR) ≤1.3 in the absence of anticoagulant therapy;
    5. Platelet count ≥120,000/mm3.

You CAN'T join if...

  • 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.

Locations

  • UCSF Medical Center not yet accepting patients
    San Francisco California 94143 United States
  • Stanford Medical Center not yet accepting patients
    Palo Alto California 94304 United States
  • University of Washington accepting new patients
    Seattle Washington 98195 United States
  • Mayo Clinic Rochester Campus accepting new patients
    Rochester Minnesota 55905 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
NorthSea Therapeutics B.V.
ID
NCT05919680
Phase
Phase 2 Liver Disease Research Study
Study Type
Interventional
Participants
Expecting 36 study participants
Last Updated