Actively Recruiting
Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics
Led by PharmaIN · Updated on 2025-09-05
74
Participants Needed
9
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of cirrhosis based on histology or clinical, radiological, or biochemical assessment and classified as Child-Pugh A or B
- Participants aged 18 to 75 years
- Body mass index (BMI) between 18 and 40 kg/m2 inclusive at screening
- Female participants must be non-pregnant, non-lactating, or of non-childbearing potential or using highly effective contraception for the entire study duration
You will not qualify if you...
- Significant medical history or physical exam abnormalities including respiratory disease requiring therapy or history of respiratory failure, cardiovascular disease or hypertension, and significant ECG abnormalities
- History of diabetes insipidus, syndrome of inappropriate antidiuretic hormone secretion, or disorders with fluid or sodium imbalance
- Significant kidney disease
- Hepatic encephalopathy or altered mental status requiring hospitalization; variceal or upper gastrointestinal bleeding; or type 1 hepatorenal syndrome with acute kidney injury within 3 months before screening
- Acute-on-chronic liver failure
- Recipient of a patent transjugular intrahepatic portosystemic shunt (TIPS)
- Known positive HIV confirmed by viral load
- Acute infections including acute viral hepatitis (chronic hepatitis B patients are eligible if stable treatment for at least 3 months)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Arizona Liver Health
Chandler, Arizona, United States, 85224
Actively Recruiting
2
Southern California Research Center
Coronado, California, United States, 92118
Actively Recruiting
3
Tandem Clinical Research
Marrero, Louisiana, United States, 70072
Actively Recruiting
4
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
6
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
7
Methodist Health System, Dallas Medical Center
Dallas, Texas, United States, 75203
Actively Recruiting
8
VA North Texas Healthcare System
Dallas, Texas, United States, 75216
Actively Recruiting
9
Texas Liver Institute
San Antonio, Texas, United States, 78215
Actively Recruiting
Research Team
C
Cynthia C Jones
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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