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Study of tenofovir disoproxil versus placebo for children aged 2-12 years with chronic hepatitis B infection

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What is this trial about?

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

This clinical trial investigates the effectiveness of a medication called tenofovir disoproxil fumarate in treating children with chronic hepatitis B infection. The study compares this medication against placebo in children aged 2 to under 12 years who have had hepatitis B for at least 6 months. The purpose is to evaluate how well the medication works in reducing the amount of hepatitis B virus in the blood of pediatric patients.

The medication is given as film-coated tablets in various strengths (245 mg, 204 mg, 163 mg, 123 mg) or as granules (33 mg/g), taken by mouth. The treatment period lasts for 192 weeks, which is approximately 3.7 years. During this time, doctors will monitor the amount of virus in the blood and check how well the liver is functioning through blood tests.

The study measures several important outcomes, including how many children achieve very low levels of the hepatitis B virus in their blood, improvements in liver function, and changes in certain proteins in the blood that indicate how the body is responding to the infection. The study also monitors the safety of the medication by checking bone density and other health indicators throughout the treatment period.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
You will be randomly assigned to receive either tenofovir disoproxil fumarate (TDF) or a placebo
The medication will be provided in the form of film-coated tablets or granules, depending on your age and weight
You will take the medication by mouth daily
Step 2
48-week evaluation period
Your hepatitis B virus (HBV) levels in blood will be measured
Your liver function will be monitored through blood tests
Your doctor will check for changes in your hepatitis B markers
Your bone density will be measured to monitor any changes
Step 3
Long-term follow-up
Treatment and monitoring will continue through week 192 (approximately 4 years)
Regular blood tests will check your virus levels and liver function
Bone density measurements will be repeated
Your doctor will continue monitoring for any changes in your hepatitis B status
Step 4
Final evaluation
A final assessment of your response to treatment will be conducted
Your doctor will evaluate all test results including virus levels, liver function, and bone density
The total duration of the study will be from 2013 to 2026

Who can join the trial?

13 criteria

Age between 2 and 12 years old (male or female)
Body weight must be at least 10 kg
Must have chronic hepatitis B infection for at least 6 months
Must have either positive or negative hepatitis B e antigen (a protein that indicates if the virus is actively multiplying)
Must have hepatitis B virus levels of at least 100,000 copies per milliliter in blood
Must have liver enzyme (ALT) levels at least 1.5 times higher than the normal range
Must have good kidney function with creatinine clearance of at least 80 mL/min/1.73m² (a measure of how well kidneys filter blood)
Must have adequate blood counts:
- Neutrophils (white blood cells that fight infection) at least 1,500 per mm³
- Hemoglobin (protein that carries oxygen) at least 10 grams per deciliter
- Must not have previously taken tenofovir DF (the study medication)
- If previously treated with interferon-alfa, must have stopped it at least 6 months before screening
- If previously treated with other hepatitis B medications, must have stopped them at least 16 weeks before screening
- Females must have a negative pregnancy test at screening

Who cannot join the trial?

13 criteria

Previous treatment with tenofovir or other antiviral medications for hepatitis B
Active liver disease from causes other than hepatitis B (such as other viral infections or autoimmune conditions)
Children younger than 2 years or older than 12 years of age
Known allergies or sensitivity to the study medication or its components
Severe kidney problems (as tenofovir is processed by the kidneys)
Participation in other clinical trials within the past 30 days
Serious medical conditions that could interfere with study participation
Inability to swallow tablets or take oral medication
HIV co-infection or other serious viral infections
History of liver cancer or cirrhosis (severe scarring of the liver)
Pregnant or breastfeeding females
Mental conditions that could affect the ability to follow study procedures
Abnormal blood test results that suggest other serious health conditions

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Verified sites

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

Spitalul Clinic De Boli Infectioase Si Pneumoftiziologie Victor Babes Craiova
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Craiova, Romania
Spitalul Clinic De Urgenta Pentru Copii Grigore Alexandrescu
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Bucharest, Romania

Trial locations

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Investigated drugs

Tenofovir Disoproxil Fumarate (TDF) is an antiviral medication used to treat chronic hepatitis B infection. It works by blocking an enzyme that the hepatitis B virus needs to multiply, which helps reduce the amount of virus in the body. This medication is commonly used in both adults and children to manage chronic hepatitis B infection and helps prevent liver damage caused by the virus.

Tenofovir Disoproxil

What is already known about the treatment

Tenofovir Disoproxil Fumarate (TDF) - An antiviral medication administered orally that belongs to the class of nucleotide reverse transcriptase inhibitors, primarily used in the treatment of chronic hepatitis B infection. The drug works by interfering with viral DNA replication, effectively suppressing the hepatitis B virus from multiplying in the body. This medication has been extensively studied in clinical trials and is approved for use in both adults and children, with ongoing research focusing on its efficacy in pediatric populations aged 2 to 12 years. TDF has become a cornerstone in the management of chronic hepatitis B due to its proven antiviral efficacy and established safety profile.

Investigated diseases

Hepatitis B - A viral infection that affects the liver, caused by the hepatitis B virus (HBV). The infection can be either acute (short-term) or chronic (long-term), with chronic cases more common when infection occurs in childhood. The virus attacks liver cells and can cause inflammation of the liver. In chronic cases, the infection continues for months or years, during which the virus keeps multiplying in liver cells. The condition may show no obvious symptoms in its early stages, but can gradually lead to liver cell damage over time.