← Back to Search

Nucleoside Analog Reverse Transcriptase Inhibitor

Tenofovir disoproxil fumarate for Chronic Hepatitis B

Phase 3
Waitlist Available
Led By Florence Wong, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All patients with inactive chronic hepatitis B, defined as someone who has HBV DNA ≤ log4, eAg-ve, eAb+, HBsAg+ve and normal ALT persistently for >6 months
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three years
Awards & highlights

Study Summary

This trial is testing if a common antiviral medication can help people with inactive chronic hepatitis B by reducing the amount of the virus in their liver and improving long-term outcome.

Eligible Conditions
  • Chronic Hepatitis B

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three years
This trial's timeline: 3 weeks for screening, Varies for treatment, and three years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Seroconversion from hepatitis B surface antigen positive to hepatitis B surface antibody positive

Side effects data

From 2018 Phase 4 trial • 213 Patients • NCT02195518
13%
Upper respiratory tract infection
6%
Blood creatine phosphokinase increased
4%
Hypophosphataemia
3%
Hepatic steatosis
2%
Diarrhoea
2%
Urinary tract infection
2%
Nephrolithiasis
2%
Hepatocellular carcinoma
2%
Insomnia
2%
Hypertension
1%
Steatohepatitis
1%
Toothache
1%
Flatulence
1%
Influenza
1%
Weight decreased
1%
Chronic gastritis
1%
Hepatic cyst
1%
Anaemia
1%
Headache
1%
Cholecystitis acute
1%
Pharyngitis
1%
Hypokalaemia
1%
Rash
1%
Coagulopathy
1%
Tibia fracture
1%
Nasopharyngitis
1%
Pyrexia
1%
Fibula fracture
1%
Renal cyst
1%
Alanine aminotransferase increased
1%
Blood uric acid increased
1%
Cholelithiasis
1%
Blood phosphorus decreased
1%
Protein urine present
1%
Transaminases increased
1%
Ultrasound liver abnormal
1%
White blood cells urine positive
1%
Gallbladder polyp
1%
Hepatic function abnormal
1%
Benign prostatic hyperplasia
1%
Prostatitis
1%
Vaginal inflammation
1%
Depression
1%
Rhinitis allergic
1%
Dry eye
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tenofovir Disoproxil Fumerate 300 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tenofovir disoproxil fumarateExperimental Treatment1 Intervention
300 mg, orally, once a day for 3 years or when sAg+ve seroconverts to sAb+ve whichever comes earlier
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tenofovir disoproxil fumarate
2008
Completed Phase 4
~12550

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,475 Previous Clinical Trials
485,040 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,084 Previous Clinical Trials
848,429 Total Patients Enrolled
Florence Wong, MDPrincipal InvestigatorUniversity Health Network -Toronto General Hospital
2 Previous Clinical Trials
124 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who does this study require as participants?

"Up to 50 patients, aged 18 to 75, who currently have a chronic hepatitis b infection may be eligible for this trial. In order to qualify, patients must also have had inactive chronic hepatitis B for longer than 6 months. This is defined as someone who has HBV DNA ≤ log4, eAg-ve, eAb+, HBsAg+ve and normal ALT."

Answered by AI

What are the most frequent indications for this therapy?

"In addition to human immunodeficiency virus type 1 (HIV-1) infection, this medication is frequently used to treat other viral infections like hepatitis b. It is also sometimes used as a part of a therapeutic procedure for certain adult patients who have suppressed the HIV-1 virus."

Answered by AI

Does the FDA recognize this therapy as an official treatment?

"Our analysts have determined that this Phase 3 trial's safety merits a 3 on our 1-to-3 scale."

Answered by AI

Are there any more spots available in this trial for new participants?

"From what is detailed on clinicaltrials.gov, this trial is no longer recruiting patients. This study was initially posted on 1/26/2016, with the most recent update on 11/1/2022. However, there are 362 other studies that are still looking for patients."

Answered by AI

Is this the first time this proposed therapy has been studied?

"As of right now, there are 69 clinical trials testing this intervention. 25 of those are in the third and final stage. Even though a majority of the trials are based in Boylston, Massachusetts, there are 1,095 total locations running these sorts of tests."

Answered by AI

Could those below the age of 45 still participate in this research opportunity?

"This trial is for adults aged 18 to 75. If you are looking for a clinical trial for a minor, there are 43 trials. If you are looking for a clinical trial for seniors, there are 289 trials."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Use of TDF in Patients With Inactive Chronic Hepatitis B Infection
Florence Wong 2016. "Use of TDF in Patients With Inactive Chronic Hepatitis B Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02600117.
~5 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top