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Tenofovir DF for Chronic Hepatitis B

Phase 3

Waitlist Available

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hepatitis B e antigen (HBeAg)-positive or HBeAg-negative

Creatinine Clearance ≥ 80 mL/min/1.73m^2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 192

Awards & highlights

Pivotal Trial

Summary

This trial will compare the effectiveness of the medication tenofovir DF to a placebo in treating children aged 2-12 with chronic hepatitis B infection.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of Tenofovir DF include digestive issues, headache, fatigue, and potential impacts on bone density and kidney function. The exact side effects in children are being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My kidneys are functioning well.

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I weigh at least 10 kilograms.

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I am between 2 and 11 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 192

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 192

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 192 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on AASLD Normal Range) at Week 192

Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on AASLD Normal Range) at Week 48

Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on Central Lab Normal Range) at Week 192

+14 more

Side effects data

From 2013 Phase 3 trial • 87 Patients • NCT00352053

36%

Vomiting

27%

Sinusitis

24%

Nausea

24%

Cough

22%

Diarrhoea

18%

Abdominal Pain

18%

Nasopharyngitis

18%

Upper Respiratory Tract Infection

18%

Dizziness

13%

Headache

11%

Oral Herpes

11%

Tracheobronchitis

11%

Gastritis

Neutropenia

Tonsillitis

Anorexia

Pyrexia

Pneumonia

Jaundice

Acute Sinusitis

Rhinitis

Furuncle

Hordeolum

Hypertriglyceridaemia

Bronchospasm

Constipation

Osteopenia

Pneumocystis Jiroveci Pneumonia

Conjunctivitis

Body Tinea

Gastroenteritis

Bronchopneumonia

Cryptococcosis

Respiratory Tract Infection

Urinary Tract Infection

Convulsion

Impetigo

Proteinuria

Acne

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Tenofovir DF

All TDF

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Tenofovir DF (Open-label Treatment)Experimental Treatment1 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 Treatment1 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 Treatment1 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 Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tenofovir DF

2002

Completed Phase 4

~560