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New treatment option for Cirrhosis, Liver
Official title Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics
ClinicalTrials.gov ID: NCT05490888
What this study is testing
What is PHIN-214 Subcutaneous injection?
PHIN-214 Subcutaneous injection is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for cirrhosis, liver.
Also referred to as Terlipressin derivative.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
You likely can't join if
- Significant abnormalities in medical history or on physical examination, including: respiratory disease requiring therapy or history of respiratory...
- History of diabetes insipidus, syndrome of inappropriate antidiuretic hormone secretion, or any other disorder associated with fluid or sodium...
- Significant kidney disease
- Hepatic encephalopathy (HE) or altered mental status requiring hospitalization; variceal bleeding or upper gastrointestinal bleeding; or type 1...
- Acute-on-chronic liver failure.
- Recipient of a patent transjugular intrahepatic portosystemic shunt (TIPS).
See the full eligibility 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 Key
- Significant abnormalities in medical history or on physical examination, including: respiratory disease requiring therapy or history of respiratory failure, cardiovascular disease or hypertension, electrocardiogram...
- 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...
- Acute-on-chronic liver failure.
- Recipient of a patent transjugular intrahepatic portosystemic shunt (TIPS).
- Known positive HIV serology confirmed by HIV viral load.
- people with acute infections, including acute viral hepatitis (people with chronic hepatitis B are eligible if treatment regimen is stable ≥ 3 months prior to study inclusion).
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Coronado, California, United States
- Marrero, Louisiana, United States
- Rochester, Minnesota, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Coronado, California, United States; Marrero, Louisiana, United States; Rochester, Minnesota, United States; Cleveland, Ohio, United States; Philadelphia, Pennsylvania, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.