Not recruiting

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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

6 criteria

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 trial?

3 criteria

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.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Cliniques Universitaires Saint-Luc
Responsive
Woluwe-Saint-Lambert, Belgium
Grand Hopital De Charleroi
Responsive
Charleroi, Belgium
Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium

Trial locations

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Investigated drugs

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.

What is already known about the treatment

Nucleos(t)ide Analogue – This medication is typically administered orally in the form of tablets. It is currently being studied in clinical trials for its effects on chronic hepatitis B infection, particularly in understanding how ethnicity influences viral outcomes after stopping treatment. The main therapeutic use of nucleos(t)ide analogues is to manage chronic hepatitis B by reducing viral replication. At the molecular level, these medications work by inhibiting the viral DNA polymerase enzyme, which is essential for the virus to reproduce. They are classified as antiviral agents, specifically targeting hepatitis B virus.

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.