Condition: Intestinal Failure Associated Liver Disease · Sponsor: NorthSea Therapeutics B.V.
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.
This description comes directly from the study's public registry record.
Michelle Yokley · +31 (0) 35 760 65 05 · michelle.yokley@northseatherapeutics.com
Always discuss trial participation with your own doctor first.
| Mayo Clinic Scottsdale Campus | Scottsdale, Arizona, United States | Recruiting |
| University of California San Francisco Medical Center | San Francisco, California, United States | Recruiting |
| MedStar Georgetown University Hospital | Washington D.C., District of Columbia, United States | Not Yet Recruiting |
| Emory University School of Medicine | Atlanta, Georgia, United States | Recruiting |
| The University of Chicago Medical Center | Chicago, Illinois, United States | Recruiting |
| Boston Children's Hospital | Boston, Massachusetts, United States | Recruiting |
| Henry Ford Hospital | Detroit, Michigan, United States | Recruiting |
| Mayo Clinic Rochester Campus | Rochester, Minnesota, United States | Recruiting |
| Mount Sinai Medical Center | New York, New York, United States | Recruiting |
| Duke University Medical Center | Durham, North Carolina, United States | Recruiting |
| The Cleveland Clinic | Cleveland, Ohio, United States | Recruiting |
| Vanderbilt University School of Medicine | Nashville, Tennessee, United States | Recruiting |
+ 1 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05919680