Not recruiting

Study on the Safety and Effectiveness of Terbinafine for 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 the medication Terbinafine in patients with chronic hepatitis B. Chronic hepatitis B is a long-term infection of the liver caused by the hepatitis B virus. The study aims to explore how well Terbinafine works in reducing the activity of the virus in the body and to assess its safety and tolerability in patients. Terbinafine is commonly used to treat fungal infections, but this study is investigating its potential benefits for hepatitis B.

Participants in the study will receive either Terbinafine or a placebo, which looks like the medication but does not contain the active ingredient. The study will also examine the effects of Terbinafine when used alone or in combination with another medication called Tenofovir, which is already used to treat hepatitis B. The trial will last for a period of 10 weeks, during which participants will take the medication orally in the form of tablets.

The main goal of the study is to see if Terbinafine can reduce the levels of the virus in the blood and to monitor any side effects that may occur. By the end of the study, researchers hope to gather enough information to determine if Terbinafine is a safe and effective treatment option 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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a series of tests to ensure normal liver function and other health parameters.
Eligibility criteria include being between 18 and 60 years old, having chronic hepatitis B for more than 6 months, and meeting specific health requirements.
Step 2
Medication administration
Participants are divided into two groups based on their viral load and current treatment status. Group A includes those not currently using antiviral medication, while Group B includes those treated with tenofovir for more than 6 months.
Participants receive either terbinafine or a placebo. Terbinafine is administered in the form of 250 mg tablets, taken orally.
Step 3
Treatment duration
The treatment period lasts for 10 weeks. During this time, participants continue to take the assigned medication as instructed.
Step 4
Monitoring and follow-up
Throughout the trial, regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes blood tests to measure levels of hepatitis B virus and liver function tests.
Participants are observed for any side effects or adverse reactions to the medication.
Step 5
End of treatment evaluation
At the end of the 10-week treatment period, a final evaluation is conducted. This includes measuring the decline in hepatitis B surface antigen and viral DNA levels.
The safety and tolerability of terbinafine are also assessed.

Who can join the trial?

19 criteria

Age between 18 and 60 years.
Confirmed **chronic hepatitis B** for more than 6 months. This means a long-term infection with the hepatitis B virus.
Specific levels of **HBV DNA**, which is the genetic material of the hepatitis B virus, depending on the group you are in.
Can be either **HBeAg-positive** or **HBeAg-negative**. These are markers in the blood that show different stages of hepatitis B infection.
Not currently using any antiviral medication if in Group A, or only using **tenofovir** for more than 6 months if in Group B. Tenofovir is a medication used to treat hepatitis B.
Normal liver function tests, which include:
**Liver stiffness** measured by a test called Fibroscan® should be 7.0 kiloPascal (kPa) or less.
**Alanine aminotransferase (ALT)** and **aspartate aminotransferase (AST)** levels should be 1.25 times the upper limit of normal or less. These are enzymes that help assess liver health.
**Thrombocytes** (a type of blood cell) should be between 150-400 billion per liter.
**Total bilirubin** should be between 0-17 micromoles per liter. Higher levels might be accepted if due to a condition called Gilbert syndrome.
**Albumin** levels should be within the normal range of 35-50 grams per liter. Albumin is a protein made by the liver.
**Prothrombin Time (PT)** should be within the normal range of 9.5-12.5 seconds. This test measures how well your blood clots.
**Alkaline phosphatase (ALP)** and **Gamma-glutamyltransferase (GGT)** should be within normal values, which are 40-120 units per liter and 0-40 units per liter, respectively. These are enzymes related to liver function.
**Body mass index (BMI)** should be between 17.0 and 35.0 kg/m². BMI is a measure of body fat based on height and weight.
Blood and other tests at screening should be normal or not significant according to the investigator's assessment.
Women who can have children must not be pregnant or breastfeeding at the start of the study. A pregnancy test will be done at screening.
Women who can have children and men who are not surgically sterilized must agree to use effective birth control from the start of the study until the last visit.
No recent history (less than 3 months) of any significant health conditions that could affect safety or study results, as judged by the investigator.
Must provide written informed consent before any study-related procedures are done.

Who cannot join the trial?

9 criteria

Patients with other types of liver diseases besides chronic hepatitis B cannot participate. Chronic hepatitis B is a long-lasting infection of the liver caused by the hepatitis B virus.
Individuals who are pregnant or breastfeeding are not eligible to join the study.
People who have a history of allergic reactions to the study medication, terbinafine, cannot take part. Terbinafine is a medication used to treat fungal infections.
Participants who are currently taking medications that might interfere with the study drug are excluded.
Individuals with severe medical conditions that could affect the study's results are not allowed to participate.
Patients who have participated in another clinical trial within the last 30 days are not eligible.
Anyone with a history of alcohol or drug abuse in the past year cannot join the study.
Individuals with a compromised immune system, meaning their body's defense against infections is weakened, are excluded.
People who are unable to follow the study procedures or attend the required visits are not eligible.

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Verified
Amsterdam UMC
Amsterdam, The Netherlands

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Investigated drugs

Terbinafine
is a medication commonly used to treat fungal infections. In this clinical trial, it is being investigated for its potential to inhibit a specific process in the hepatitis B virus, which could help manage chronic hepatitis B. The study aims to see if terbinafine can be effective on its own or when used alongside another medication.
Tenofovir
is a medication that is often used to treat hepatitis B and HIV infections. In this trial, it is used in combination with terbinafine to explore if the two medications together can provide better results in managing chronic hepatitis B.

Terbinafine

What is already known about the treatment

Terbinafine – Terbinafine is administered orally in tablet form. It is currently being investigated in clinical trials for its potential use in treating chronic hepatitis B. The main therapeutic indication being explored is its ability to inhibit HBx-mediated cccDNA transcription, which is crucial in the replication of the hepatitis B virus. Terbinafine works by interfering with the synthesis of ergosterol, a key component of fungal cell membranes, and is classified as an antifungal agent. However, its role in hepatitis B treatment is still under investigation, focusing on its safety and efficacy in this new application.

Investigated diseases

Chronic Hepatitis B – Chronic Hepatitis B 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 progresses slowly, often without noticeable symptoms in the early stages. As it advances, individuals may experience fatigue, jaundice, and abdominal discomfort. Chronic infection can result in liver scarring, known as cirrhosis, and potentially lead to liver failure. The virus is primarily spread through contact with infectious body fluids, such as blood.