Tenofovir DF for Chronic Hepatitis B

Recruiting at 20 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

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary objective of this study is to evaluate the antiviral efficacy of tenofovir disoproxil fumarate (tenofovir DF; TDF) versus placebo in pediatric population (aged 2 to \< 12 years at the time of enrollment) with chronic hepatitis B (CHB) infection.

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 Tenofovir DF safe for humans?

Tenofovir disoproxil fumarate (TDF) is generally considered safe and well-tolerated for treating chronic hepatitis B, with studies showing a good safety profile over several years of use. ^{1 2 3 4 5}

What makes Tenofovir Disoproxil Fumarate unique for treating chronic hepatitis B?

Tenofovir Disoproxil Fumarate (TDF) is unique because it is an oral medication that effectively treats chronic hepatitis B by inhibiting the virus's ability to replicate, and it is also used in treating HIV. It has shown strong antiviral activity and a good safety profile in both clinical trials and real-world settings. ^{1 4 6 7 8}

What data supports the effectiveness of the drug Tenofovir Disoproxil Fumarate for treating chronic hepatitis B?

Research shows that Tenofovir Disoproxil Fumarate (TDF) is effective in treating chronic hepatitis B, even in patients who have not responded to other treatments. It has been shown to control the virus and is considered safe for long-term use. ^{1 3 4 9 10}

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. Australia pubmed.ncbi.nlm.nih.gov

Three-year efficacy and safety of tenofovir in nucleos(t)ide analog-naïve and nucleos(t)ide analog-experienced chronic hepatitis B patients. [2017]

2. China pubmed.ncbi.nlm.nih.gov

[Efficacy of 48-week tenofovir disoproxil fumarate therapy in patients who were unresponsive to nucleoside-analogue treatments]. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Low-dose tenofovir is more potent than adefovir and is effective in controlling HBV viremia in chronic HBeAg-negative hepatitis B. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Tenofovir rescue therapy for chronic hepatitis B patients after multiple treatment failures. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of Tenofovir Disoproxil Fumarate in Chronic Hepatitis B: A 3-Year, Prospective, Real-World Study in France. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Tenofovir Disoproxil Orotate in Chronic Hepatitis B Patients Previously Treated with Tenofovir Disoproxil Fumarate: Multicenter, Open-Label, Prospective Study. [2021]

7. Spain pubmed.ncbi.nlm.nih.gov

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

8. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of tenofovir disoproxil fumarate therapy in nucleoside-analogue naive Iranian patients treated for chronic hepatitis B. [2020]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Tenofovir disoproxil fumarate: in chronic hepatitis B. [2021]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

A Multi-Center, Double-Blind Randomized Controlled Phase III Clinical Trial to Evaluate the Antiviral Activity and Safety of DA-2802 (Tenofovir Disoproxil Orotate) and Viread (Tenofovir Disoproxil Fumarate) in Chronic Hepatitis B Patients. [2022]