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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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Excluded Approach)
Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Failure Approach)
Secondary outcome measures
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
+24 moreSide effects data
From 2013 Phase 3 trial • 87 Patients • NCT0035205336%
Vomiting
27%
Sinusitis
24%
Nausea
24%
Cough
22%
Diarrhoea
18%
Abdominal Pain
18%
Nasopharyngitis
18%
Upper Respiratory Tract Infection
18%
Dizziness
13%
Headache
11%
Tracheobronchitis
11%
Oral Herpes
11%
Gastritis
9%
Tonsillitis
9%
Neutropenia
9%
Anorexia
9%
Pyrexia
7%
Pneumonia
7%
Acute Sinusitis
7%
Hypertriglyceridaemia
7%
Jaundice
7%
Hordeolum
7%
Bronchospasm
7%
Furuncle
7%
Rhinitis
7%
Constipation
7%
Osteopenia
4%
Pneumocystis Jiroveci Pneumonia
4%
Conjunctivitis
4%
Body Tinea
4%
Bronchopneumonia
4%
Gastroenteritis
2%
Respiratory Tract Infection
2%
Cryptococcosis
2%
Convulsion
2%
Urinary Tract Infection
2%
Impetigo
2%
Proteinuria
2%
Acne
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Tenofovir DF
All TDF
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
Find a Location
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,082 Previous Clinical Trials
842,751 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,745 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My kidneys are functioning well.I weigh at least 10 kilograms.The amount of hepatitis B virus in your blood is very high (100,000 copies/mL or more).You must have enough white blood cells (ANC) and a minimum level of hemoglobin in your blood.I am between 2 and 11 years old.You have had hepatitis B virus (HBV) for six or more months.You must have a negative pregnancy test before participating in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Tenofovir DF (Open-label Extension Phase)
- Group 2: Tenofovir DF (Open-label Treatment)
- Group 3: Placebo to match TDF (Blinded Randomized Treatment)
- Group 4: Tenofovir DF (Blinded Randomized Treatment)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA greenlit Tenofovir DF for public consumption?
"Tenofovir DF is a Phase 3 drug, which means that while there is some evidence of its efficacy, there is also extensive safety data. Our team rates it as a 3 on our safety scale."
Answered by AI
What is the primary purpose of Tenofovir DF?
"Tenofovir DF can be used to effectively treat human immunodeficiency virus type 1 (hiv-1) infection, therapeutic procedure, and hepatitis b, chronic."
Answered by AI
Are people who are middle-aged or older being sought out for this experiment?
"2 is the floor and 11 the ceiling for age eligibility in this particular experiment."
Answered by AI
Who meets the screening requirements to take part in this clinical research project?
"The eligibility requirements for this trial state that potential participants must have been diagnosed with hepatitis b, be aged between 2 and 11 years old, and have chronic hepatitis b. A total of 90 patients are required for this clinical study."
Answered by AI
Are there any more places available for people who want to take part in this experiment?
"This trial is not enrolling patients at the moment. According to the study's page on clinicaltrials.gov, it was first posted on December 6th, 2012 and was last edited on July 19th, 2022. However, there are 292 clinical trials actively searching for patients with hepatitis b, chronic and 69 trials for Tenofovir DF actively enrolling participants."
Answered by AI
What other medical research has been conducted using Tenofovir DF?
"69 clinical trials are currently underway to study Tenofovir DF. Phase 3 trials, which are the most advanced, number 25. There are multiple locations for these trials, but most are in Boylston, Massachusetts. In total, there are 1,095 trial sites for Tenofovir DF."
Answered by AI
Could you provide an estimate for the number of locations where this research is being conducted?
"This study is currently being conducted at Phoenix Children's Hospital in Phoenix, University of California, San Francisco in San Francisco, and Cincinnati Children's Hospital Medical Center in Cincinnati, amongst 5 other hospitals."
Answered by AI
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