Evaluating PHIN-214 for treating liver cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of PHIN-214, a derivative of terlipressin, in patients with Child-Pugh A and B liver cirrhosis. The study consists of two parts: the first part assesses a single dose of PHIN-214, while the second part involves administering multiple daily doses over 28 days. The goal is to determine the maximum tolerated dose and understand the pharmacokinetics and pharmacodynamics of the drug. Participants will receive subcutaneous injections of PHIN-214 to observe its effects on portal hypertension and renal function.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

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. Participants may be male or female aged 18 to 75 years.
3. Body mass index (BMI) within the range 18 to 40 kg/m2 (inclusive) at screening.
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

Key Exclusion Criteria:

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. History of diabetes insipidus, syndrome of inappropriate antidiuretic hormone secretion, or any other disorder associated with fluid or sodium imbalance.
3. Significant kidney disease
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. Acute-on-chronic liver failure.
6. Recipient of a patent transjugular intrahepatic portosystemic shunt (TIPS).
7. Known positive HIV serology confirmed by HIV viral load.
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).

Where it's running

• Arizona Liver Health
  Chandler, Arizona, United States Recruiting
• Southern California Research Center
  Coronado, California, United States Recruiting
• Tandem Clinical Research
  Marrero, Louisiana, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting
• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Cynthia C Jones
• Email: PHIN.214001@pharmain.com
• Phone: 206-568-1450

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.