Study on Apixaban for Patients with Intrahepatic Non-Cirrhotic Portal Hypertension

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What is this study about?

This clinical trial is focused on studying a condition known as intrahepatic non-cirrhotic portal hypertension (INCPH). 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 it occurs without the presence of liver cirrhosis. The trial will evaluate the effects of a medication called apixaban, which is a blood thinner, to see if it can help prevent or reduce the formation of blood clots in the portal vein system. Participants in the study will receive either Eliquis 2.5 mg film-coated tablets, which contain apixaban, or a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to assess the impact of taking apixaban over a period of 24 months on the development or worsening of blood clots in the portal vein system. This includes areas such as the splenic and mesenteric veins, as well as the main portal vein and its branches. The study will involve regular check-ups and imaging tests, such as CT scans, to monitor the condition of the veins and ensure the safety and well-being of the participants.

Participants will be randomly assigned to receive either the active medication or the placebo, and neither the participants nor the researchers will know which treatment each participant is receiving. This approach helps to ensure that the results of the study are unbiased and reliable. The trial is expected to last for about two years, during which time participants will be closely monitored for any changes in their condition.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age and medical condition. The condition being studied is intrahepatic non-cirrhotic portal hypertension.

Participants must be between 18 and 90 years old. Women of childbearing age must use specific forms of contraception.

2 randomization and medication assignment

Participants are randomly assigned to receive either the medication apixaban or a placebo. Apixaban is a film-coated tablet taken orally.

The dosage for apixaban is 2.5 mg, taken twice daily.

3 treatment period

The treatment period lasts for 24 months. During this time, participants continue to take their assigned medication as instructed.

The main goal is to observe the effect of the medication on the occurrence or extension of thrombosis in the portal venous system.

4 monitoring and assessments

Participants undergo regular monitoring, including CT scans, to assess any changes in the portal venous system.

These assessments are conducted with a centralized imaging review to ensure accuracy and consistency.

5 completion of the study

At the end of the 24-month period, the study concludes. The primary endpoint is the cumulative incidence of thrombosis occurrence or extension.

Results are analyzed to determine the effectiveness of apixaban compared to the placebo.

Who Can Join the Study?

Patients must be between 18 and 90 years old.
Both men and women can participate.
Women who can have children must use birth control methods such as pills, an intrauterine device (IUD), or other mechanical methods.
Patients must have proper prevention measures against bleeding from varices, which are swollen veins, as recommended by the European Association for the Study of the Liver (EASL).
Patients must have Intrahepatic Non-Cirrhotic Portal Hypertension (INCPH), which is a condition related to blood flow in the liver. This is determined by:
- No cirrhosis (liver scarring) found in a liver biopsy, and at least one sign specific to portal hypertension.
- No cirrhosis found in a liver biopsy, at least one sign not specific to portal hypertension, and at least one histological sign (tissue examination) for INCPH.
- If no liver biopsy is available, two reliable liver stiffness measurements using a special scan called Fibroscan must be less than 10 kPa, along with at least one sign specific to portal hypertension.

Who Cannot Join the Study?

Patients with intrahepatic non-cirrhotic portal hypertension cannot participate. This is a condition where there is high blood pressure in the veins of the liver, but not due to liver scarring.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, meaning they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oncopole Claudius Regaud	Toulouse	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Cvuztb Hkgrnkqdrvy Uzctmnhrbnocg Rwyua	Reims	France
Bvbudjfa Ukxstpnvhh Hyschitk Coyfmj	Besançon	France
Crnhot Hpdjfqzrhem Rtfpwjjr Utqlndhzeprwi Dt Tdsiv	Tours	France
Cbmphk Hpzviftbiks Rsnsfafw Dcreamuamwanta	Angers	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	24.06.2024

Trial locations

Investigated drugs:

Apixaban

Apixaban is a medication used in this clinical trial to help prevent blood clots in patients with a specific liver condition called intrahepatic non-cirrhotic portal hypertension (INCPH). The trial aims to see if taking apixaban for 24 months can reduce the occurrence or worsening of blood clots in the veins around the liver, such as the splenic, mesenteric, and portal veins.

Investigated diseases:

Non-cirrhotic portal hypertension

Intrahepatic Non-Cirrhotic Portal Hypertension – This condition involves increased blood pressure in the portal vein system, which carries blood from the digestive organs to the liver, without the presence of liver cirrhosis. It can lead to the development of varices, which are enlarged veins that can cause complications if they rupture. The disease progresses as the pressure in the portal vein increases, potentially leading to the formation of blood clots in the portal venous system. Over time, this can result in the extension of thrombosis, affecting additional veins such as the splenic or mesenteric veins. The condition may cause symptoms like abdominal pain, swelling, and digestive issues due to impaired blood flow.

Trial ID:

2024-514348-95-00

Protocol code:

P170916J

NCT ID:

NCT04007289

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Apixaban for Patients with Intrahepatic Non-Cirrhotic Portal Hypertension

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