For Patients

DO YOU SUFFER FROM LIVER CIRRHOSIS?

Cirrhosis of the liver can cause high portal vein pressure due to reduced passage of blood through the fibrotic liver.

This can cause pooling of blood below the liver in an area called the "splanchnic bed", reducing the blood volume in the arteries

If the brain senses low blood volume in the arteries, it may send signals to the kidneys to retain lots of salt and water in an attempt to restore effective blood volume.

The excess salt and water can "weep" from the liver and the lymphatic system and collect in the abdomen as fluid called "ascites."

When too much ascites accumulates, the patient may require physical removal of the fluid with a large bore needle, called a "paracentesis" clinic procedure.

If clinical trials demonstrate safety and efficacy and if approved by the FDA, PHIN-214 may be used to lower portal pressure and shut down the signaling to the kidneys to retain excessive amounts of salt and water, thereby decreasing the ascites fluid.

In animal studies, PHIN-214 has been shown to decrease the high blood pressure in the portal vein that provides blood flow to the liver, which indicates that it could have a therapeutic effect in humans.

Our long term goal of PHIN-214 is to develop this potential new drug therapy to help you or your loved ones to decrease or eliminate the fluid accumulation that is often the result of advanced liver cirrhosis.

PHIN-214 is an investigational drug therapy that has not been approved by the FDA or any other regulatory agency around the world.

CLINICAL TRIAL OF PHIN-214

If you have compensated or decompensated liver cirrhosis, meaning that you may have experienced ascites, you may be eligible to participate in the Phase 1b safety trial of PHIN-214. The first step in the clinical development process is to evaluate safety (this trial also includes exploratory measures of efficacy).

PHASE 1

Clinical Trial Information on clinicaltrials.gov

Currently enrolling in Arizona and Minnesota.

Eligible patients will have early cirrhosis where liver function is near normal (Child-Pugh A) or the cirrhosis has progressed to ascites, classified as Child-Pugh B.

PHASE 2

Planned for 2023 at approximately ten sites across the US.

Patients with cirrhosis classified as Child-Pugh A or B.

Inclusion Criteria:

  1. All genders, 18 to 70 years old.
  2. Body mass index within the range of 18 to 40 kg/m2 (inclusive) at screening.
  3. Patients with liver cirrhosis confirmed by reliable biopsy (within 12 months) or reliable Fibroscan >15kPa at screening.

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 abnormalities.
  2. History of diabetes insibidus, syndrome of inappropriate antidiuretic hormone secretion or any other disorder associated with fluid or sodium imbalance.
  3. Significant kidney disease.
  4. Hepatic encephalopathy.
  5. Recipient of a transjugular intrahepatic portosystemic shunt (TIPS).
  6. Known positive HIV serology confirmed by HIV viral load.
IF YOU FEEL YOU MAY BE ELIGIBLE, Then click on the link below

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