RecruitingPHASE2INTERVENTIONAL

Study of Tenofovir Alafenamide (TAF) in Children and Teen Participants With Chronic Hepatitis B Virus Infection

This clinical trial is investigating a new medication, tenofovir alafenamide (TAF), for young people aged between 2 and 17 who have chronic (long-term) hepatitis B. The main goals are to find out how well TAF works, if it's safe to use, and how well children and teenagers can tolerate it compared to a placebo (a dummy medicine with no active drug). Researchers also want to learn the best doses for children of different ages and weights. Participants will be either treatment-naive (not received previous treatment) or treatment-experienced (received previous treatment) for chronic hepatitis B. The study hopes to offer a new treatment option for managing this condition in younger individuals.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Gilead Sciences

Enrolment target

150

Start

01 Nov 2016

Estimated completion

01 Oct 2029

Chronic Hepatitis B

What is this study about?

This study is a clinical trial, which means it's a carefully planned research study to test a new medicine. In this case, the medicine is called tenofovir alafenamide, or TAF for short. Doctors want to see if TAF can help children and teenagers who have chronic hepatitis B. 'Chronic' means it's a long-lasting condition, not just a short illness.

The main idea behind this study is to compare TAF with a 'placebo.' A placebo is like a dummy medicine – it looks the same as the real drug but doesn't have any active ingredients. This comparison helps doctors understand if any changes seen are truly due to TAF or if they might happen anyway. They'll be looking at how well TAF works, if it's safe to use, and if children and teens can take it without too many problems. They also want to figure out the best amount of medicine (dose) for different age groups.

Finding new ways to treat chronic hepatitis B in young people is really important. This study could help doctors understand if TAF is a good option to manage the virus and improve the health of children and teenagers affected by it.

Key takeaways

This study tests a new medicine (TAF) for children and teens with long-term hepatitis B.
It aims to find out if TAF is safe and works better than a dummy pill (placebo).
Eligible participants are aged 2 to 17, with confirmed chronic hepatitis B.
Regular clinic visits, blood tests, and health checks will be part of the study.
Participation is voluntary, and you can withdraw at any time.
This research could lead to new treatment options for young people with hepatitis B.

Who may be eligible?

To join this study, children and teenagers need to be between 2 and 17 years old. They must have long-term hepatitis B, which means they've had the virus for at least six months.

There are also requirements concerning a child's weight and certain blood test results related to their liver and the hepatitis B virus. Children who have already had treatment for hepatitis B, as well as those who haven't, might be able to join. Parents or legal guardians will need to give their written permission, and the child will also be asked to agree if they're old enough.

However, some conditions would mean a child can't take part. This includes if they are pregnant or breastfeeding, have other serious liver diseases not caused by hepatitis B, or have other serious health problems like heart, lung, or kidney disease. They also can't have other infections like hepatitis C, HIV, or hepatitis D. All participants will need to have a normal heart tracing (ECG).

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child between 2 and 17 years old?
Has your child been diagnosed with long-term hepatitis B (for at least 6 months)?
Is your child able to come for regular clinic visits?
Does your child meet the weight requirements for their age group?
Does your child have generally good health apart from hepatitis B?
Is your child not pregnant or breastfeeding (if applicable)?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will receive either the study drug (TAF) or a placebo. This will be given as a pill. They will have regular visits to the clinic for check-ups, blood tests, and other assessments to monitor their health, how the medicine is working, and to check for any side effects. These visits will be needed for as long as they are on the study treatment, and there will be follow-up appointments after they stop taking the medicine. The total length of time your child would be involved in the study is not specified but clinical trials usually involve multiple visits over several months or even longer.

Potential risks and benefits

Taking part in a clinical trial might offer some potential benefits, such as access to a new medicine that isn't yet widely available, and close medical monitoring. The information gathered may also help others in the future. However, there are also potential risks, as with any medicine; TAF might cause side effects, or it might not work effectively for your child. The placebo group will not receive active treatment for a period, which means their condition will not be directly treated by the study medicine during that time. It's important to remember that participation is completely voluntary, and you have the right to withdraw your child from the study at any time, for any reason, without it affecting their future medical care.

Locations (62)

Children's Hospital of Los Angeles
Verified postcode
Los Angeles, United States· Recruiting
Rady Childrens Hospital
Verified postcode
San Diego, United States· Recruiting
University of California, San Francisco (UCSF)
Verified postcode
San Francisco, United States· Active not recruiting
Children's Hospital Colorado
Verified postcode
Aurora, United States· Active not recruiting
University of Miami/Schiff Center for Liver Diseases
Verified postcode
Miami, United States· Withdrawn
AdventHealth Medical Group
Verified postcode
Orlando, United States· Withdrawn
Children's Healthcare of Atlanta
Verified postcode
Atlanta, United States· Withdrawn
Indiana University School of Medicine
Verified postcode
Indianapolis, United States· Recruiting
Johns Hopkins University
Verified postcode
Baltimore, United States· Recruiting
University of Minnesota Masonic Children's Hospital
Verified postcode
Minneapolis, United States· Withdrawn
Children's Mercy Hospital
Verified postcode
Kansas City, United States· Recruiting
Children's Hospital & Medical Center
Verified postcode
Omaha, United States· Withdrawn

Common questions

What is chronic hepatitis B?

Chronic hepatitis B is a long-lasting liver infection caused by the hepatitis B virus. It can cause serious health problems over time if not managed.

What is a placebo?

A placebo is a 'dummy' pill that looks just like the real study medicine but doesn't contain any active drug. It helps doctors compare the real medicine's effects.

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

No, in this type of study, neither you, your child, nor the study doctors will know who is getting the real medicine and who is getting the placebo. This is to make sure the results are fair.

What are the common side effects of TAF?

The study aims to better understand the safety of TAF in children and teenagers. Your study doctor will explain any known side effects and what to look out for.

What happens after the study ends?

At the end of the study, the researchers will share the results to help advance medical knowledge. Your child's doctor will discuss their ongoing care after the study.

How to find out more

Gilead Study Team

gs-us-320-1092@gilead.com Official trial record

Always speak to your GP or specialist before deciding to take part in a study.