Phase
Condition
Hyponatremia
Scar Tissue
Hepatic Fibrosis
Treatment
PHIN-214 Subcutaneous injection
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion 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-childbearingpotential or using highly efficient contraception for the full duration of the study
Exclusion
Key Exclusion Criteria:
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 historyof significant EKG abnormalities.
History of diabetes insipidus, syndrome of inappropriate antidiuretic hormonesecretion, 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 syndromewith acute kidney injury (HRS-AKI) during the previous 3 months prior to Screening.
Acute-on-chronic liver failure.
Recipient of a patent transjugular intrahepatic portosystemic shunt (TIPS).
Known positive HIV serology confirmed by HIV viral load.
Subjects with acute infections, including acute viral hepatitis (subjects withchronic hepatitis B are eligible if treatment regimen is stable ≥ 3 months prior tostudy inclusion).
Study Design
Study Description
Connect with a study center
Arizona Liver Health
Chandler, Arizona 85224
United StatesSite Not Available
Arizona Liver Health
Chandler 5289282, Arizona 5551752 85224
United StatesActive - Recruiting
Southern California Research Center
Coronado, California 92118
United StatesSite Not Available
Southern California Research Center
Coronado 5339663, California 5332921 92118
United StatesActive - Recruiting
Tandem Clinical Research
Marrero, Louisiana 70072
United StatesSite Not Available
Tandem Clinical Research
Marrero 4332628, Louisiana 4331987 70072
United StatesActive - Recruiting
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
United StatesActive - Recruiting
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
United StatesActive - Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesActive - Recruiting
Methodist Health System, Dallas Medical Center
Dallas, Texas 75203
United StatesSite Not Available
Texas Liver Institute
San Antonio, Texas 78215
United StatesSite Not Available
Methodist Health System, Dallas Medical Center
Dallas 4684888, Texas 4736286 75203
United StatesActive - Recruiting
VA North Texas Healthcare System
Dallas 4684888, Texas 4736286 75216
United StatesActive - Recruiting
Texas Liver Institute
San Antonio 4726206, Texas 4736286 78215
United StatesActive - Recruiting

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