RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-01-03
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05490888

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. History of cirrhosis based on histology or a combination of clinical, radiological, or biochemical assessment and classified as Child-Pugh A or B
  2. 2. Participants may be male or female aged 18 to 75 years.
  3. 3. Body mass index (BMI) within the range 18 to 40 kg/m2 (inclusive) at screening.
  4. 4. 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
  1. 1. 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.
  2. 2. History of diabetes insipidus, syndrome of inappropriate antidiuretic hormone secretion, or any other disorder associated with fluid or sodium imbalance.
  3. 3. Significant kidney disease
  4. 4. 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.
  5. 5. Acute-on-chronic liver failure.
  6. 6. Recipient of a patent transjugular intrahepatic portosystemic shunt (TIPS).
  7. 7. Known positive HIV serology confirmed by HIV viral load.
  8. 8. 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).

Contacts and Locations

Study Contact

Cynthia C Jones
CONTACT
206-568-1450
PHIN.214001@pharmain.com

Principal Investigator

Cynthia C Jones
STUDY_CHAIR
PharmaIN

Study Locations (Sites)

Arizona Liver Health
Chandler, Arizona, 85224
United States
Southern California Research Center
Coronado, California, 92118
United States
Tandem Clinical Research
Marrero, Louisiana, 70072
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Methodist Health System, Dallas Medical Center
Dallas, Texas, 75203
United States
Texas Liver Institute
San Antonio, Texas, 78215
United States

Collaborators and Investigators

Sponsor: PharmaIN

  • Cynthia C Jones, STUDY_CHAIR, PharmaIN

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-03
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2022-01-03
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • Terlipressin
  • Cirrhosis
  • Vasoconstrictor
  • Refractory Ascites

Additional Relevant MeSH Terms

  • Cirrhosis, Liver
  • Liver Fibrosis
  • Ascites Hepatic