Change of Renal Function and Bone Mineral Density in CHB Patients Switch From TDF to TAF vs. Maintaining TDF (SWITAF)

December 19, 2022 updated by: George Lau, Humanity and Health Research Centre

Change of Renal Function and Bone Mineral Density Marker in Chronic Hepatitis B Patients Switching From TDF to TAF vs. Maintaining TDF

In Chronic hepatitis B (CHB) patients receiving long-term sequential Neucleos(t)ides(NAs), majority of these CHB patients experienced drug resistance and switched to Tenofovir disoproxil fumaratate(TDF). However, some of patients on long term TDF experienced impairment of renal function and bone mineral density. After Tenofovir alafenamide(TAF) was in clinical practice, these group of patients got an clinical option to switch from TDF to TAF. The investigators designed a prospective cohort study to evaluate the real life effectiveness and safety in participants with chronic HBV infection switch from TDF to TAF vs. maintaining on TDF.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Tenofovir disoproxil fumarate(TDF) have been associated with renal toxicity and reduced bone mineral density. Tenofovir alafenamide(TAF) is a novel tenofovir prodrug that reduces tenofovir plasma concentrations by 90%, thereby decreasing off-target side-effects. The investigators aimed to assess whether efficacy, safety, and tolerability were non-inferior in participants switched to TAF versus in those remaining on TDF. This is a prospective clinical study.

Study Type

Interventional

Enrollment (Anticipated)

1000

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

  • Hong Kong
      • Hong Kong, Hong Kong, 00852
        • Recruiting
        • Humanity and Health GI and Liver Centre
        • Contact:
        • Principal Investigator:
          • George KK Lau, MD
        • 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

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Chronic hepatitis B,
  2. Antiviral experienced,
  3. Currently on long term TDF anti-HBV treatment,
  4. HBV DNA < 6 log IU/ml (LLOD)
  5. Able to sign the consent form of anticipating in the study

Exclusion Criteria:

  1. Co-infected with HCV, HIV or other viral hepatitis,
  2. Diagnosis of HCC

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Maintaining on TDF
Maintaining on Tenofovir Disoproxil Fumarate(TDF) 300mg daily
Drug: Tenofovir disoproxil fumarate(TDF)
300 mg tablet administered orally once daily
Other Names:
  • VIREAD®
Experimental: TDF switch to TAF
Tenofovir Disoproxil Fumarate(TDF) 300mg daily switch to Tenofovir Alafenamide(TAF) 25mg daily
Drug: Tenofovir alafenamide(TAF)
25 mg tablet administered orally once daily
Other Names:
  • VEMLIDY®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antiviral response of TAF
Time Frame: 60 months
Anti-HBV effectiveness of TAF compared with TDF in treatment experienced CHB patients
60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of renal function and bone mineral density in CHB patients switching to TAF
Time Frame: 60 months
Change of renal function and bone mineral density from baseline in CHB patients of TAF a group compared with TDF group
60 months

Collaborators and Investigators

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

Sponsor

Humanity and Health Research Centre

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)

December 1, 2017

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

September 20, 2017

First Submitted That Met QC Criteria

November 24, 2017

First Posted (Actual)

November 29, 2017

Study Record Updates

Last Update Posted (Actual)

December 21, 2022

Last Update Submitted That Met QC Criteria

December 19, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HumanityHGLC

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.

No

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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