Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B

October 7, 2023 updated by: Teng-Yu Lee, Taichung Veterans General Hospital

Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B: An Open Label, Randomized Controlled Trial

To compare the efficacy and renal safety of tenofovir alafenamide (TAF) versus entecavir (ETV) in the chronic hepatitis B patients.

Study Overview

Status

Recruiting

Detailed Description

With high antiviral potency and low drug resistance rate, both ETV and tenofovir disoproxil fumarate (TDF) have been recommended as the first-line antiviral therapy for chronic hepatitis B (CHB). However, risk of renal dysfunction remains an issue in TDF long-term therapy. Tenofovir alafenamide (TAF) is a novel prodrug of tenofovir and is formulated to deliver the active metabolite to target cells more efficiently than TDF at lower doses, thereby reducing systemic exposure to tenofovir. Importantly, TAF had improved renal safety as compared to TDF. TAF has been approved for treating CHB since 2017; however, it is still unknown whether the efficacy and renal safety of TAF is compatible to those of ETV. The investigators aim to conduct an open label, randomized controlled trial comparing TAF with ETV for assessing their efficacy and renal safety in CHB patients. The eligible CHB patients are randomly assigned (1:1) to receive TAF or ETV. After allocation to TAF group or ETV group, study subjects will receive therapy for 3 years (144 weeks).

Study Type

Interventional

Enrollment (Estimated)

420

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Taichung, Taiwan
        • Recruiting
        • Taichung Veterans General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients more than 20 years old
  2. Chronic hepatitis B patients
  3. Patients who were indicated for hepatitis B virus antiviral therapy

Exclusion Criteria:

  1. Decompensated liver disease (Child-Pugh B &C)
  2. End stage renal disease (eGRF < 15 ml/min/1.73m2)
  3. Prior use of nucleot(s)ide analogues for chronic hepatitis B
  4. Prior use of interferon for chronic hepatitis B within six months
  5. Known history of human immunodeficiency virus or hepatitis C virus co-infection
  6. Concurrent other uncontrolled malignancy
  7. Women in pregnancy or lactation
  8. Cannot conform to the study protocol of this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tenofovir alafenamide group
Study subjects will receive tenofovir alafenamide 25 mg/tab once daily for 3 years (144 weeks).
Tenofovir alafenamide 25mg/tab once daily
Other Names:
  • Vemlidy
Active Comparator: Entecavir group
Study subjects will receive entecavir 0.5 mg/tab once daily for 3 years (144 weeks).
Entecavir 0.5mg/tab once daily
Other Names:
  • Baraclude

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HBV viral suppression
Time Frame: After 48-week therapy of Tenofovir alafenamide or entecavir
proportion of patients with hepatitis B virus(HBV) -DNA suppression
After 48-week therapy of Tenofovir alafenamide or entecavir
Renal safety: Change of estimated glomerular filtration rate
Time Frame: After 48-week therapy of Tenofovir alafenamide or entecavir
Change of estimated glomerular filtration rate
After 48-week therapy of Tenofovir alafenamide or entecavir

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Normalization alanine aminotransferase (ALT)
Time Frame: After 48-week therapy of Tenofovir alafenamide or entecavir
proportion of patients with ALT normalization
After 48-week therapy of Tenofovir alafenamide or entecavir
HBsAg loss
Time Frame: After 48-week therapy of Tenofovir alafenamide or entecavir
proportion of patients with HBsAg loss
After 48-week therapy of Tenofovir alafenamide or entecavir
HBeAg loss
Time Frame: After 48-week therapy of Tenofovir alafenamide or entecavir
proportion of patients with HBeAg loss
After 48-week therapy of Tenofovir alafenamide or entecavir
Bone mineral density
Time Frame: After 48-week therapy of Tenofovir alafenamide or entecavir
change of bone mineral density
After 48-week therapy of Tenofovir alafenamide or entecavir

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Teng-Yu Lee, MD, PhD, Taichung Veterans General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2019

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2033

Study Registration Dates

First Submitted

April 28, 2019

First Submitted That Met QC Criteria

April 30, 2019

First Posted (Actual)

May 1, 2019

Study Record Updates

Last Update Posted (Actual)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 7, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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