Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Randomized, Double-Blind Evaluation of the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Patients with Chronic Hepatitis B Infection

This important study is investigating a medicine called Tenofovir (Viread) for children who have chronic Hepatitis B, a long-lasting liver infection. Researchers want to find out how well this medicine works to lower the amount of the Hepatitis B virus in children's blood and if it's safe for them to take. They are comparing different doses of Tenofovir with a placebo, which is a tablet that looks like the medicine but contains no active ingredients. This helps them understand the medicine's true effects. The study aims to provide clearer guidance on treating young people with this condition.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Gilead Sciences Inc., Gilead Sciences Inc.

Enrolment target

Start

07 Nov 2024

Hepatitis B Infection

What is this study about?

This study is all about helping children who have a long-term (chronic) Hepatitis B infection. Hepatitis B is a virus that can affect the liver over many years. When children have this infection, doctors want to make sure they get the best possible treatment to keep them healthy.

The main aim of this study is to look at a medicine called Tenofovir, which you might know as Viread. We want to understand two key things: first, how good it is at reducing the amount of the Hepatitis B virus in a child's body, and second, if it's safe for children to use. To do this fairly, some children will receive Tenofovir, and others will receive a placebo – a tablet that looks exactly the same but doesn't contain any active medicine. Neither the children nor the doctors will know who is getting what, which helps us get unbiased results.

By comparing the children who take Tenofovir with those who take the placebo, we can figure out if Tenofovir genuinely helps reduce the virus and improves liver health. The study will also look at different strengths of Tenofovir, including tablets and granules, to see which works best and is easiest for children to take. Information from this study is crucial for doctors to make informed decisions about treating children with Hepatitis B in the future.

Key takeaways

A study for children with long-term Hepatitis B.
Compares a medicine (Tenofovir/Viread) to a dummy tablet (placebo).
Aims to see if the medicine safely reduces the virus and helps the liver.
Children will have regular blood tests and check-ups.
Information from this study will help children with Hepatitis B in the future.

Who may be eligible?

This study is open to both boys and girls of any age who have been diagnosed with a long-term Hepatitis B infection.

Quick self-check

Is your child diagnosed with long-term (chronic) Hepatitis B?
Is your child any age?
Is your child a boy or a girl?
Are you able to attend regular clinic appointments for your child?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If your child takes part, they would receive either the study medicine (Tenofovir/Viread) or a dummy tablet (placebo). This would be in the form of coated tablets or granules. You, and the doctors, won't know which your child is receiving.

Throughout the study, your child will have regular check-ups and blood tests. These tests help the doctors keep track of how much of the Hepatitis B virus is in their blood and how well their liver is working. These visits are important to monitor their health and the effects of the treatment.

The study is planned to last for a significant period. While the main results will be looked at after 48 weeks (about 11 months), some follow-up checks might go on for up to 192 weeks (about 3 and a half years) to understand the longer-term effects. The research team will explain the exact schedule of visits and assessments.

Potential risks and benefits

Taking part in a study like this might offer your child access to a new treatment that could help manage their Hepatitis B infection, potentially reducing the amount of virus in their body and improving their liver health. However, as with all medicines, there could be side effects, even with the placebo. The doctors and nurses will closely monitor your child for any problems and explain these in detail. Remember, your child can stop taking part in the study at any time, for any reason, without it affecting their ongoing medical care.

Locations (1)

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Romania

Common questions

What is chronic Hepatitis B?

Chronic Hepatitis B means your child has had the Hepatitis B virus for a long time, which can affect their liver.

What is Tenofovir (Viread)?

Tenofovir, also known as Viread, is a medicine often used to treat Hepatitis B infection.

What does 'placebo' mean?

A placebo is a dummy tablet that looks like the actual medicine but doesn't contain any active ingredients. It helps researchers judge if the medicine really works.

Will my child know if they are getting the medicine or the placebo?

No, neither your child nor the doctors will know if they are receiving the study medicine or the placebo. This is to ensure the results are fair.

How long will the study last for my child?

The main part of the study will involve checks for about 48 weeks, but some follow-up might continue for up to 192 weeks.