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NCT05919680 · ClinicalTrials.gov registry record · Phase 2
A Study of NST-6179 in Subjects With Intestinal Failure-Associated Liver Disease (IFALD).
A Phase 2 study of Intestinal Failure Associated Liver Disease, sponsored by NorthSea Therapeutics B.V..
- Recruiting
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 13
- Study locations
NCT05919680 is a Phase 2 study of Intestinal Failure Associated Liver Disease that is actively recruiting participants, run by NorthSea Therapeutics B.V.. The registered enrollment target is 36 participants. The trial reports 13 study locations across 13 states.
The verdict
NCT05919680, a Phase 2 study of Intestinal Failure Associated Liver Disease, is actively recruiting participants, sponsored by NorthSea Therapeutics B.V..
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 13
- Study locations
Study 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 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.
Conditions Studied
Interventions
- OTHER Matched Placebo
- DRUG NST-6179 Part A
- DRUG NST-6179 Part B
Study Locations (13)
Arizona
- Mayo Clinic Scottsdale Campus - Scottsdale
California
- University of California San Francisco Medical Center - San Francisco
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Georgia
- Emory University School of Medicine - Atlanta
Illinois
- The University of Chicago Medical Center - Chicago
Massachusetts
- Boston Children's Hospital - Boston
Michigan
- Henry Ford Hospital - Detroit
Minnesota
- Mayo Clinic Rochester Campus - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2024-01-15 |
| Est. Completion | 2025-06-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05919680
The ClinicalTrials.gov registry entry for NCT05919680 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NorthSea Therapeutics B.V., which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Intestinal Failure Associated Liver Disease appearing as the primary indexed condition, and to 3 interventions - of which Matched Placebo is the first listed.
NCT05919680 reports 13 study locations spanning 13 distinct geographic areas - top geographies include Arizona, California, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT05919680 about?
NCT05919680 is a clinical study titled "A Study of NST-6179 in Subjects With Intestinal Failure-Associated Liver Disease (IFALD).". 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 ...
What is the current status of trial NCT05919680?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2024-01-15. Estimated completion is 2025-06-30.
What conditions does trial NCT05919680 study?
This clinical trial studies the following conditions: Intestinal Failure Associated Liver Disease.
What interventions are being tested in trial NCT05919680?
The interventions under investigation include: Matched Placebo (OTHER), NST-6179 Part A (DRUG), NST-6179 Part B (DRUG).
Who is sponsoring clinical trial NCT05919680?
This trial is sponsored by NorthSea Therapeutics B.V., which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05919680 being conducted?
This trial has 13 study locations across Arizona, California, District of Columbia, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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