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

Sponsor
Humanity and Health Research Centre (Other)
Overall Status
Recruiting
CT.gov ID
NCT03356834
Collaborator
(none)
1,000
Enrollment
1
Location
2
Arms
70
Anticipated Duration (Months)
14.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tenofovir alafenamide(TAF)
  • Drug: Tenofovir disoproxil fumarate(TDF)
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Change of Renal Function and Bone Mineral Density Marker in Chronic Hepatitis B Patients Switching From TDF to TAF vs. Maintaining TDF
Actual Study Start Date :
Dec 1, 2017
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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®

    		•
    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®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Antiviral response of TAF [60 months]

      Anti-HBV effectiveness of TAF compared with TDF in treatment experienced CHB patients

    Secondary Outcome Measures

    1. Improvement of renal function and bone mineral density in CHB patients switching to TAF [60 months]

      Change of renal function and bone mineral density from baseline in CHB patients of TAF a group compared with TDF group

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Humanity and Health GI and Liver Centre Hong Kong Hong Kong 00852

    Sponsors and Collaborators

    • Humanity and Health Research Centre

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    George Lau, Humanity & Healthy Medical Group President, Humanity and Health Research Centre
    ClinicalTrials.gov Identifier:
    NCT03356834
    Other Study ID Numbers:
    • HumanityHGLC
    First Posted:
    Nov 29, 2017
    Last Update Posted:
    Aug 30, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by George Lau, Humanity & Healthy Medical Group President, Humanity and Health Research Centre
    Chronic hepatitis B
    Efficacy, safety, and tolerability
    Tenofovir alafenamide
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis B
    Hepatitis B, Chronic
    Hepatitis
    Hepatitis, Chronic
    Tenofovir

    Study Results

    No Results Posted as of Aug 30, 2021