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

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What is this study about?

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.

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

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

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

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 Study?

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 Study?

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

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Skwildog Conmvx Di Uiepeup Pgwirp Chwar Gtrrcno Awoefjldknsy	Bucharest	Romania
Sbwqedfi Cisgqq Di Bdol Ivnrwrzoctc St Phohkuagiskfgrmfk Vjdiee Berfy Cmkwggc	Craiova	Romania

Trial status

Country	Status	Recruitment Start
Romania	Not recruiting	27.02.2013

Trial locations

Investigated drugs:

Tenofovir Disoproxil

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.

Investigated diseases:

Chronic hepatitis B

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.

Trial ID:

2024-517526-26-00

Protocol code:

GS-US-174-0144

NCT ID:

NCT01651403

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?