The NAVIGATE Study, a Clinical Trial in NASH Cirrhosis

Why Study NASH Cirrhosis?

There is currently no treatment for NASH cirrhosis, a progressive disease that may result in liver failure and increased mortality. Currently, the only cure for NASH cirrhosis is a liver transplantation.

The NAVIGATE Study seeks to change this, offering patients and their families the first potential therapy targeted specifically at NASH cirrhosis.

What is the Goal of the Study?

An earlier clinical trial showed that belapectin, the candidate treatment, may prevent the development of esophageal varices in patients with compensated NASH cirrhosis and was well tolerated and appeared safe. While the results were exciting, they need to be confirmed through continued testing on a larger number of patients. “Compensated” means the patient is not yet experiencing the more severe symptoms of NASH cirrhosis. When these severe symptoms occur, the cirrhosis is considered ”decompensated.”

Development of esophageal varices is thought to be an early sign of more serious complications of NASH cirrhosis. Varices happen when scars in the liver block the flow of blood from the digestive system through the liver, causing internal blood vessels to dilate, similar to varicose veins in the legs.

The NAVIGATE Study looks to prevent the development of these varices and provide a better outcome for patients with NASH cirrhosis.

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What is Involved in the Trial?

The NAVIGATE Study is a Phase 2b/3 trial, broken into multiple stages each lasting 18 months.

The medication will be administered intravenously (IV) every other week, so travel to the trial site is required. Reimbursement for travel and lodging is available.

The first, smaller Phase 2b stage of the trial will compare two dosages of belapectin against a placebo. Patients will either receive a 2mg/kg of lean body mass (LBM) or 4mg/kg LBM or a simple saline solution, a placebo, via a one hour intravenous infusion.

The study is “double blind,” so neither you nor the doctors will know whether you are receiving the medication or the placebo. You have a 2 out of 3 chance of being on drug vs placebo.

Doctors will perform an endoscopy at the beginning of the study, and after an 18-month course of therapy, to determine whether esophageal varices have developed or not.

After all patients have received at least 18 months of therapy, the results will be analyzed to determine which dosage of belapectin, if any, is most effective.

The larger Phase 3 study will test this newly selected optimal dosage against placebo in additional patients. Patients who participated in the Phase 2b part of the trial will be able to continue in the study for another 18 months, if they desire.

After a further 18 months of treatment in the Phase 3 stage, these additional patients will also undergo an endoscopy to evaluate if varices have developed.

The results of the Phase 2b and Phase 3 will be analyzed to determine if it is appropriate for belapectin to become an approved therapy for NASH cirrhosis.

Do I Qualify for the NAVIGATE Study?

The NAVIGATE Study has very specific criteria for participation:

  • You must have a diagnosis of NASH cirrhosis, confirmed through a liver biopsy
    • An existing biopsy available in your medical dossier can be sufficient
    • Otherwise, a biopsy will be performed at the beginning of the study
  • You must be 18 to 75 years old
  • You must exhibit clinical signs of portal hypertension, meaning at least two of the following:
    • Platelet count below 150,000/mm3
    • Spleen size of 15 cm or larger, documented by a non-invasive imaging test (e.g. an echography)
    • Collateral blood vessels, documented clinically or by an imaging test
  • You must NOT have esophageal varices. This will be confirmed by an esophago-gastric endoscopy

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Talk to your doctor about the full list of criteria for inclusion or exclusion.

Where Do I Go for Treatment?

Study sites for the NAVIGATE Study are currently located throughout the U.S. Sites are also participating in Canada, Mexico, and the rest of the world.

Study Sites in the U.S.

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