Study on Stopping Tenofovir Alafenamide, Tenofovir Disoproxil, and Entecavir in Patients with Chronic Hepatitis B

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What is this study about?

This clinical trial is focused on studying the effects of stopping certain medications in people with chronic hepatitis B infection. Chronic hepatitis B is a long-term infection of the liver caused by the hepatitis B virus. The study will involve medications that are commonly used to treat this condition, including Vemlidy (which contains the active substance tenofovir alafenamide), Tenofovir disoproxil (found in products like Viread and Tenofovir disoproxil Viatris), and Entecavir (found in products like Baraclude and Entecavir Krka). These medications are taken as film-coated tablets.

The purpose of the study is to understand how stopping these medications affects the virus in people who have been on treatment for a long time. The study will look at how the virus behaves after the treatment is stopped, particularly in people who are HBeAg negative, which means they do not have a specific protein in their blood that is often present in active hepatitis B infections. Participants will be monitored for changes in their health and the virus over a period of time after they stop taking the medication.

During the study, participants will take either the medication or a placebo, and their health will be closely monitored. The study will last for several months, and researchers will check the levels of the virus in the blood and other health markers to see how the virus responds to the treatment being stopped. The goal is to see if the virus remains under control without the medication and to understand the role of ethnicity in these outcomes. This information could help improve future treatment plans for people with chronic hepatitis B.

1 joining the study

Participation begins after meeting specific criteria, including age between 18 and 75 years, and a diagnosis of chronic hepatitis B infection for at least 6 months.

Eligibility requires being HBeAg negative at the start of treatment and having been under continuous nucleos(t)ide analogue treatment with specific viral load and liver enzyme levels.

2 medication administration

The study involves the use of various medications in the form of film-coated tablets taken orally. These include Vemlidy 25 mg, Tenofovir disoproxil 245 mg, Baraclude 1 mg, Entecavir 1 mg, and Viread 245 mg.

The specific dosage and frequency of each medication are determined based on individual treatment plans.

3 treatment cessation

The main objective is to investigate the effects of stopping nucleos(t)ide analogue treatment in patients with chronic hepatitis B.

The study monitors the viral outcomes after treatment cessation, focusing on the control of the virus and liver enzyme levels.

4 monitoring and evaluation

The primary endpoint is to achieve viral control, defined as HBV DNA levels below 2000 IU/mL and liver enzyme levels within normal limits, 72 weeks after stopping treatment.

A secondary endpoint is the loss of HBsAg, a marker of hepatitis B infection, at week 72 after treatment cessation.

5 study duration

The estimated end date for the study is December 31, 2025.

Recruitment for the study is expected to start on October 10, 2024.

Who Can Join the Study?

  • Must be between 18 and 75 years old.
  • Must have chronic hepatitis B, which means testing positive for HBsAg or HBV DNA for at least 6 months.
  • Must have started treatment while being HBeAg negative. This means a specific protein related to the virus is not present in the blood.
  • Must be under continuous treatment with nucleos(t)ide analogues (NA), which are medications used to treat hepatitis B.
  • Must have HBV DNA levels below the local limit of detection for at least 36 months when stopping treatment, or levels less than or equal to 2 log IU/mL for at least 48 months when stopping treatment. HBV DNA is the genetic material of the hepatitis B virus.
  • Must have ALT levels that are less than or equal to 2 times the upper limit of normal (40 U/L) on two separate tests taken at least 6 months apart. One of these tests must be done during the screening process. ALT is a liver enzyme that helps doctors understand liver health.

Who Cannot Join the Study?

  • Patients with chronic hepatitis B infection cannot participate. This is a long-term infection of the liver caused by the hepatitis B virus.
  • Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. This means people who might be at higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Algemeen Stedelijk Ziekenhuis Campus Aalst Aalst Belgium
Katholieke Universiteit te Leuven Leuven Belgium
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Algemeen Ziekenhuis Klina Brasschaat Belgium
CHU Saint Pierre Brussels Belgium
Algemeen Ziekenhuis Delta Roeselare Belgium
Az Maria Middelares Gent Gent Belgium
AZ Turnhout Turnhout Belgium
Grand Hopital De Charleroi Charleroi Belgium
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Vitaz Sint-Niklaas Belgium
Algemeen Ziekenhuis Damiaan Oostende Ostend Belgium
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Jessa Ziekenhuis Hasselt Belgium
Gasthuiszusters Antwerpen Antwerp Belgium
CHC MontLegia Liege Belgium
Ziekenhuis Oost Limburg Genk Belgium
CHU Helora La Louviere Belgium
Vrije Universiteit Brussel Jette Belgium
University Childrens Hospital Queen Fabiola Brussels Belgium
Ceqcjgptm Untpjjuhdifanu Sxzlqchzy Woluwe-Saint-Lambert Belgium
Swpsg el Pqtqxxperj Namur Belgium
Utgmkilmyx Od Aitlcmf Edegem Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
10.10.2024

Trial locations

Nucleos(t)ide Analogues are medications used to treat chronic hepatitis B infections. They work by interfering with the virus’s ability to replicate, helping to control the infection and reduce the amount of virus in the body. In this clinical trial, the role of these medications is to assess the effects of stopping their use in patients with HBeAg negative chronic hepatitis B, to understand how ethnicity might influence the outcomes when the treatment is interrupted.

Investigated diseases:

Chronic Hepatitis B Infection – This is a long-term infection of the liver caused by the hepatitis B virus. It can lead to inflammation and damage to liver cells over time. The disease often begins with mild symptoms or none at all, making it difficult to detect early. As it progresses, individuals may experience fatigue, jaundice, and abdominal pain. The virus can remain in the body for years, potentially leading to more severe liver conditions. The progression of the disease varies, with some individuals experiencing stable conditions while others may develop complications.

Trial ID:
2024-511016-25-00
NCT ID:
NCT04779970
Trial Phase:
Therapeutic exploratory (Phase II)

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