NASH cirrhosis is the end stage of non-alcoholic steatohepatitis (NASH), where scar tissue and regenerative nodules resulting from the inflammation and fibrosis of NASH have replaced healthy liver tissue, preventing the liver from functioning normally.
NASH cirrhosis will soon become the number one reason for liver transplants.
The NAVIGATE Study is the only adaptive Phase 2b/3 clinical trial focused on NASH cirrhosis.
There is currently no treatment for NASH cirrhosis. The NAVIGATE Study seeks to change this, offering patients and their families the first potential therapy targeted specifically at NASH cirrhosis.
A previous clinical trial showed that a drug named belapectin may prevent the development of esophageal varices in patients with compensated NASH cirrhosis. Varices are an early sign for the development of serious complications in NASH cirrhosis.
To be part of the study, you must have a confirmed diagnosis of NASH cirrhosis with no evidence of esophageal varices.
Approximately 50% of cirrhotic NASH patients with portal hypertension do not have varices when first diagnosed.
Clinical trials are research studies involving human volunteers to see how safe and effective a potential medication is in preventing, treating, or curing a particular disease or condition.
There are substantial benefits to volunteering to be in a research study, but participating isn’t right for everyone.
The NAVIGATE Study has been designed to integrate the Standard of Care of NASH cirrhosis patients.
Galectin Therapeutics Inc. has developed several overarching principles to guide its conduct of clinical research in light of COVID-19. Number one among these is the safety of patients and study site personnel. Health authorities have provided guidance for the conduct of clinical studies during this pandemic, and we follow this guidance carefully. Participants are encouraged to contact their study site directly with any questions or concerns.