Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics
Condition(s) studied
Investigational drug(s) / intervention(s)
PHIN-214 Subcutaneous injection: subcutaneous injection(s) with PHIN-214 terlipressin derivative
Study summary
This 2-part study will evaluate PHIN-214 given as a single one-time dose (Part 1) and in multiple doses (given as daily doses for 28-days) (in Part 2). Specifically, this study evaluates PHIN-214, to determine the safety, tolerability, and pharmacokinetic effects of PHIN-214, and to establish the maximum tolerated dose or optimal beneficial dose in patients with Child Pugh A and B Cirrhosis.
Eligibility
Primary outcome measure(s)
- maximum tolerated dose or optimal beneficial dose of PHIN-214 in multiple ascending dose; safety and tolerability. — may be up to six weeks
Incidence of adverse effects (type and severity), incidence of dose limiting toxicities, changes in key laboratory measures - Pharmacokinetics of PHIN-214 — up to six weeks
plasma concentration of PHIN-214 - Pharmacokinetics of PHIN-214 metabolite — up to six weeks
plasma concentration of PHIN-214 metabolite
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Arizona Liver Health | Chandler | Arizona | Recruiting |
| Southern California Research Center | Coronado | California | Recruiting |
| Tandem Clinical Research | Marrero | Louisiana | Recruiting |
| Mayo Clinic | Rochester | Minnesota | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Recruiting |
| University of Pennsylvania | Philadelphia | Pennsylvania | Recruiting |
| Methodist Health System, Dallas Medical Center | Dallas | Texas | Recruiting |
| VA North Texas Healthcare System | Dallas | Texas | Recruiting |
| Texas Liver Institute | San Antonio | Texas | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05490888 on ClinicalTrials.gov ↗ ← All trials in the USA