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Nucleoside analogue

Tenofovir Alafenamide for Chronic Hepatitis B

Phase 4
Waitlist Available
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
No oral antiviral treatment or IFN for ≥6 months
Written informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial will help researchers understand how the antiviral drug Tenofovir alafenamide helps to reduce liver inflammation in patients with chronic hepatitis B.

Eligible Conditions
  • Chronic Hepatitis B

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have not taken oral antiviral medication or interferon for at least 6 months.
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You have given permission in writing to take part in the study.
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You have a high amount of HBV DNA in your blood.
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You are older than 18 years.
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You have had hepatitis B for at least six months.
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Your ALT levels are higher than 19 if you are female or higher than 30 if you are male, according to AASLD criteria.
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If you are a male, you need to use at least one type of contraception. If you are a female, you need to use a barrier method of contraception along with another form of contraception.
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You have a specific marker related to hepatitis B in your blood.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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
TAF-mediated reduction of inflammatory gene expression in intraheaptic immune cells
TAF-mediated reduction of intrahepatic HBV replication intermediates and cccDNA levels
TAF-mediated reduction of serological markers of HBV replication

Side effects data

From 2022 Phase 4 trial • 270 Patients • NCT03471624
1%
Nausea
1%
Hepatocellular carcinoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tenofovir Alafenamide for 24 Months

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tenofovir AlafenamideExperimental Treatment1 Intervention
Tenofovir Alafenamide 25mg, Dosed orally, once daily with or without food.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tenofovir alafenamide
FDA approved

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,456 Previous Clinical Trials
482,858 Total Patients Enrolled

Frequently Asked Questions

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

Are there any antecedent investigations into this therapeutic approach?

"Presently, 73 studies investigate this therapeutic intervention. Of which, 16 are in Phase 3 of their trials. Primarily situated near Myslowice, Maryland; 1430 locations facilitate research related to this treatment regimen."

Answered by AI

What safety assessments have been made to ensure this treatment is secure for individuals?

"As this is a Phase 4 trial, with an approved treatment protocol and existing data supporting safety, it was assigned the highest rating of 3."

Answered by AI

How many human participants are being evaluated in this clinical research?

"Verified. Reports from clinicaltrials.gov demonstrate that this particular trial is actively recruiting patients, having first been posted on 29th January 2019 and last updated 23rd August 2019. It requires 15 participants to be admitted across one site."

Answered by AI

Are there openings presently available in this clinical trial?

"Affirmative. Reports on clinicaltrials.gov show that the trial, which was first advertised in January of 2019 is currently seeking participants. In total, 15 patients are sought to be recruited from a single medical site."

Answered by AI

What indications is this treatment typically prescribed for?

"This medication is commonly prescribed for people without a prior history of treatment. Furthermore, it may be recommended to those with HIV-1 and weight at least 35 kg who have not developed resistance to darunavir."

Answered by AI
~2 spots leftby Mar 2025