Ongoing Clinical Trials for Non-Cirrhotic Portal Hypertension
There is currently 1 ongoing clinical trial investigating treatments for non-cirrhotic portal hypertension, specifically focusing on intrahepatic non-cirrhotic portal hypertension. The trial is evaluating the use of apixaban, a blood-thinning medication, to prevent or reduce blood clots in the portal vein system. This study is taking place in France and is expected to last approximately 24 months.
Clinical trial locations
Study on Apixaban for Patients with Intrahepatic Non-Cirrhotic Portal Hypertension
This trial is investigating the use of apixaban, a medication that helps prevent blood clots, in patients with intrahepatic non-cirrhotic portal hypertension. This is a liver-related condition where there is high blood pressure in the portal vein system, which carries blood from the digestive organs to the liver, but occurs without liver cirrhosis (scarring).
Inclusion criteria: To participate in this trial, patients must be between 18 and 90 years old. Both men and women can join the study. Women of childbearing age must use effective birth control methods, such as contraceptive pills, an intrauterine device, or other mechanical methods. Participants must have proper prevention measures in place against bleeding from varices, which are swollen veins, as recommended by medical guidelines. The diagnosis of intrahepatic non-cirrhotic portal hypertension must be confirmed through either a liver biopsy showing no cirrhosis along with specific signs of portal hypertension, or through two reliable liver stiffness measurements using a Fibroscan scan showing values less than 10 kPa along with at least one sign specific to portal hypertension.
Exclusion criteria: Patients who fall outside the specified age range cannot participate. Additionally, individuals who are part of a vulnerable population requiring special protection or care are excluded from the study.
Trial focus: The main goal of this study is to evaluate whether taking apixaban for 24 months can help prevent or reduce the formation and extension of blood clots in the portal venous system. This includes areas such as the splenic and mesenteric veins, as well as the main portal vein and its branches. Participants will be randomly assigned to receive either apixaban tablets at a dose of 2.5 mg taken twice daily or a placebo that looks identical but contains no active medication. Neither the participants nor the researchers will know which treatment each person is receiving, ensuring unbiased results. Throughout the 24-month treatment period, participants will undergo regular monitoring, including CT scans, to assess any changes in the portal venous system. These assessments are conducted with centralized imaging review to ensure accuracy and consistency.
Investigational drug: The medication being tested is apixaban, which is administered orally in tablet form. Apixaban works by inhibiting Factor Xa, an enzyme crucial for blood clotting, thereby reducing the risk of clot formation. It belongs to a class of medications called direct oral anticoagulants. In this trial, the therapeutic goal is to prevent or reduce the formation of blood clots in the portal venous system of patients with this specific liver condition.
Summary
Currently, there is one active clinical trial addressing intrahepatic non-cirrhotic portal hypertension, a condition involving increased blood pressure in the liver’s portal vein system without the presence of cirrhosis. This trial is taking place in France and focuses on evaluating apixaban, a blood-thinning medication, as a potential preventive treatment against blood clots in the portal venous system. The study spans 24 months and uses a randomized, placebo-controlled design to ensure reliable results. This research represents an important step in understanding how anticoagulation therapy might benefit patients with this rare liver condition.
