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Recruiting NCT05490888

Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics

Phase I Interventional Cirrhosis, Liver Liver Fibrosis Ascites Hepatic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PHIN-214 Subcutaneous injection.
Who it may be relevant to
Registry conditions: Cirrhosis, Liver, Liver Fibrosis, Ascites Hepatic. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1 Open Label Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PHIN-214 in Adults With Child Pugh A and B Cirrhosis

Overview

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.

Detailed description

PHIN-214 action has similar actions as another medication called "terlipressin or TERLIVAZ®." Terlipressin has been shown to reduce portal hypertension, improve renal function, and induce natriuresis in cirrhotic patients with ascites without hepatorenal syndrome (HRS). It is approved in several countries including the US for the treatment of bleeding esophageal varices and HRS type 1 and is usually administered using multiple IV doses given by bolus injections in the hospital.

This study is an open label, first in human study of PHIN-214. PHIN-214 is a terlipressin derivative administered subcutaneously. It is a partial V1a agonist which is designed to reduce splanchnic blood pooling and portal hypertension. A resultant increase in systemic pressure and renal arterial pressure may increase kidney perfusion and creatinine clearance.

This study will evaluate a single dose of PHIN-214 (in Part 1) and in Part 2, daily doses of PHIN-214 for up to 28-days (called multiple ascending doses) of PHIN-214 to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of PHIN-214 in subjects with advanced cirrhosis.

Interventions

  • Drug PHIN-214 Subcutaneous injection
    subcutaneous injection(s) with PHIN-214 terlipressin derivative

Primary outcome measures

  • maximum tolerated dose or optimal beneficial dose of PHIN-214 in multiple ascending dose; safety and tolerability. [Time frame: may be up to six weeks]
  • Pharmacokinetics of PHIN-214 [Time frame: up to six weeks]
  • Pharmacokinetics of PHIN-214 metabolite [Time frame: up to six weeks]
Secondary outcome measures (1)
  • Immunogenicity of PHIN-214 [Time frame: up to six weeks]

Eligibility criteria

Inclusion criteria

  • History of cirrhosis based on histology or a combination of clinical, radiological, or biochemical assessment and classified as Child-Pugh A or B
  • Participants may be male or female aged 18 to 75 years.
  • Body mass index (BMI) within the range 18 to 40 kg/m2 (inclusive) at screening.
  • Female participants must be non-pregnant, non-lactating, or of non-childbearing potential or using highly efficient contraception for the full duration of the study

Exclusion criteria

  • Significant abnormalities in medical history or on physical examination, including: respiratory disease requiring therapy or history of respiratory failure, cardiovascular disease or hypertension, electrocardiogram abnormalities or history of significant EKG abnormalities.
  • History of diabetes insipidus, syndrome of inappropriate antidiuretic hormone secretion, or any other disorder associated with fluid or sodium imbalance.
  • Significant kidney disease
  • Hepatic encephalopathy (HE) or altered mental status requiring hospitalization; variceal bleeding or upper gastrointestinal bleeding; or type 1 hepatorenal syndrome with acute kidney injury (HRS-AKI) during the previous 3 months prior to Screening.
  • Acute-on-chronic liver failure.
  • Recipient of a patent transjugular intrahepatic portosystemic shunt (TIPS).
  • Known positive HIV serology confirmed by HIV viral load.
  • Subjects with acute infections, including acute viral hepatitis (subjects with chronic hepatitis B are eligible if treatment regimen is stable ≥ 3 months prior to study inclusion).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 9 centers
  • Arizona Liver Health — Chandler
  • Southern California Research Center — Coronado
  • Tandem Clinical Research — Marrero
  • Mayo Clinic — Rochester
  • Cleveland Clinic — Cleveland
  • University of Pennsylvania — Philadelphia
  • Methodist Health System, Dallas Medical Center — Dallas
  • VA North Texas Healthcare System — Dallas
  • … and 1 more center

Identifiers

NCT: NCT05490888 · PHIN-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗