Tenofovir DF for Chronic Hepatitis B

Not currently recruiting at 25 trial locations

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Gilead Sciences

Must not be taking: Interferon, Anti-HBV, NSAIDs, others

Disqualifiers: Pregnancy, Liver disease, HIV, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates a treatment called tenofovir disoproxil fumarate (TDF) for children with chronic hepatitis B, a liver infection caused by the hepatitis B virus. The trial compares TDF's effects to a placebo to determine which more effectively fights the virus. Some children will initially receive a placebo before switching to TDF. Children with chronic hepatitis B for at least six months and a high viral load (virus count) might be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial requires that participants stop taking any anti-HBV nucleoside/nucleotide therapy at least 16 weeks before screening. If you are on such medications, you will need to stop them before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Tenofovir Disoproxil Fumarate (TDF) is generally safe for treating chronic hepatitis B. One study found that patients tolerated TDF well over time, with most maintaining low virus levels in their blood. In another study, 94.1% of patients experienced a significant reduction in the virus, indicating good prospects for long-term safety.

Further research indicated that TDF treatment improved liver function for many patients. Specifically, 82% of patients experienced virus suppression, and 66% had normal liver enzyme levels by the end of the study. These findings suggest that TDF is generally safe for people with chronic hepatitis B, with few serious side effects reported. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chronic hepatitis B?

Researchers are excited about Tenofovir Disoproxil Fumarate (TDF) for chronic Hepatitis B because it offers a different approach compared to standard treatments like interferons or other nucleos(t)ide analogs. Unlike some current options that may have significant side effects or aren't as well-tolerated, TDF is known for its strong antiviral activity and favorable safety profile. It works by directly inhibiting the replication of the Hepatitis B virus, potentially leading to better viral suppression and improved liver health over time. This makes TDF a promising option for patients who need effective, long-term management of chronic Hepatitis B.

What evidence suggests that tenofovir DF could be an effective treatment for chronic hepatitis B in children?

Research has shown that Tenofovir Disoproxil Fumarate (TDF), which participants in this trial may receive, effectively treats chronic hepatitis B. Studies found that 99.3% of patients taking TDF had low levels of the hepatitis B virus in their blood after seven years. Additionally, 80% of these patients returned to normal liver enzyme levels, indicating good liver health. TDF is approved in several countries for treating chronic hepatitis B because it controls the virus over a long period. While it may not completely cure the infection, it helps manage and suppress the virus effectively. ^{1 6 7 8 9}

Who Is on the Research Team?

Gilead Study Director

Principal Investigator

Gilead Sciences

Are You a Good Fit for This Trial?

This trial is for children aged 2 to under 12 with chronic hepatitis B. They must have a high viral load, no prior treatment with tenofovir DF, and normal or slightly elevated liver enzymes. Their blood counts need to be within certain limits, and they can't be pregnant or have been on specific hepatitis treatments recently.

Inclusion Criteria

I have never been treated with tenofovir DF for hepatitis B, but may have used other treatments.

I have tested positive or negative for the hepatitis B e antigen.

Your ALT level is higher than what is considered normal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Blinded Randomized Treatment

Participants receive either tenofovir disoproxil fumarate (TDF) or placebo for 48 or 72 weeks, depending on protocol amendment

48-72 weeks

Open-label Treatment

Participants switch to open-label TDF treatment for an additional 120 or 144 weeks, depending on protocol amendment

120-144 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label Extension

Participants may opt into continuation of treatment with open-label TDF until it is commercially available in their country

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Tenofovir Disoproxil Fumarate

Trial Overview The study tests the effectiveness of Tenofovir Disoproxil Fumarate (TDF) against a placebo in reducing the virus in kids with chronic hepatitis B. It's designed to see if TDF can safely control the virus better than not taking it.

How Is the Trial Designed?

Group I: Tenofovir DF (Open-label Treatment) Experimental Treatment 1 Intervention

Following 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3) of blinded randomized treatment, participants will switch to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).

Group II: Tenofovir DF (Open-label Extension Phase) Experimental Treatment 1 Intervention

Following the completion of study at Week 192, participants may have the option to receive open-label TDF until it is commercially available in that country for treatment of chronic HBV in participants of their age and weight.

Group III: Tenofovir DF (Blinded Randomized Treatment) Experimental Treatment 1 Intervention

Participants will receive tenofovir disoproxil fumarate (tenofovir DF; TDF) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3).

Group IV: Placebo to match TDF (Blinded Randomized Treatment) Placebo Group 1 Intervention

Participants will receive TDF placebo for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3).

Who Is Running the Clinical Trial?

Gilead Sciences

Lead Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Published Research Related to This Trial

Tenofovir disoproxil fumarate is a safe and well-tolerated oral medication approved for treating chronic hepatitis B, allowing for convenient once-daily dosing due to its long-lasting effects.

It has become a first-line treatment option for chronic hepatitis B, effective for both patients who are new to treatment and those who have previously received other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tenofovir disoproxil fumarate for the treatment of hepatitis B infection. Adusumilli, S.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4427621/

Seven-Year Efficacy and Safety of Treatment with Tenofovir ... For patients on treatment at year 7, 99.3 % maintained viral suppression (HBV DNA < 69 IU/mL), 80.0 % achieved serum alanine aminotransferase normalization, and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3002569/

Efficacy and safety of tenofovir disoproxil fumarate in ... Further follow-up of Study 103 for 96 weeks has shown that TDF treatment was able to maintain suppressed HBV DNA levels in 78% of patients, while in those ...

3. virologyj.biomedcentral.com virologyj.biomedcentral.com/articles/10.1186/s12985-025-02788-6

Hepatitis surface B antigen clearance induced by long-term ... Despite TDF's efficacy in suppressing hepatitis B virus (HBV) DNA, it rarely achieves functional cure, requiring hepatitis B surface antigen ( ...

4. gilead.com gilead.com/news/news-details/2010/vireadr-for-hepatitis-b-maintains-antiviral-suppression-with--no-development-of-resistance-through-four-years-of-treatment

Viread(R) for Hepatitis B Maintains Antiviral Suppression ... In Studies 102 and 103, the majority of patients who received Viread for up to 192 weeks experienced sustained suppression of HBV DNA levels in the blood below ...

5. isrctn.com isrctn.com/ISRCTN80908109

Effectiveness and safety of tenofovir disoproxil fumarate in ... Tenofovir disoproxil fumarate (TDF) was approved for the treatment of Chronic Hepatitis B (CHB) in the U.S. in 2008 and in China in 2013 based on Phase III ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2772947822000652

Tenofovir disoproxil fumarate therapy in patients with ... TDF treatment resulted in virological suppression in 94.1% patients. Long-term suppression of HBV can lead to fibrosis regression even in patients with CHB and ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00117676

NCT00117676 | A Study to Compare Tenofovir Disoproxil ... Long Term Treatment with Tenofovir Disoproxil Fumarate for Chronic Hepatitis B Infection is Safe and Well Tolerated and Associated with Durable Virologic ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5220271/

Efficacy and safety of tenofovir in chronic hepatitis B Virological suppression was achieved in 82% of patients, 12% of patients underwent HBeAg seroconversion and 66% of patients showed ALT normalisation by the end ...

9. bmcinfectdis.biomedcentral.com bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-021-06237-x

Short-term and long-term safety and efficacy of tenofovir ... The results showed that three groups displayed comparable 48-week liver transplant-free survival. Besides, TAF is as effective as TDF and ETV in ...