Evaluating PHIN-214 for treating liver cirrhosis
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
This study is testing a new treatment called PHIN-214 to see if it can safely help people with liver cirrhosis improve their liver function and manage related health issues.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | PharmaIN Industry-sponsored |
| Locations | 9 sites (Chandler, Arizona and 8 other locations) |
| Trial ID | NCT05490888 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a diagnosis of Child-Pugh A or B cirrhosis.
Not a fit: Patients with significant kidney disease, hepatic encephalopathy, or other serious medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve kidney function and reduce complications associated with liver cirrhosis.
How similar studies have performed: Other studies have shown success with terlipressin in treating similar conditions, suggesting potential for PHIN-214.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chandler, Arizona and 8 other locations
- 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)
- Methodist Health System, Dallas Medical Center — Dallas, Texas, United States (Recruiting)
- VA North Texas Healthcare System — Dallas, Texas, United States (Recruiting)
- Texas Liver Institute — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Cynthia C Jones
- Email: PHIN.214001@pharmain.com
- Phone: 206-568-1450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.