A Study of NST-6179 in Subjects With Intestinal Failure-Associated Liver Disease (IFALD).
Recruiting
Phase 2
Interventional Study
Intestinal Failure Associated Liver Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 16 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 36 (estimated)
- Sponsor
- NorthSea Therapeutics B.V. · Industry
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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 …
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
* 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
1. liver enzymes (ALP, AST, ALT, or GGT ≥1.5 × upper limit of normal \…
Contacts