Change of Renal Function and Bone Mineral Density in CHB Patients Switch From TDF to TAF vs. Maintaining TDF (SWITAF)
Primary Purpose
Chronic Hepatitis B
Status
Recruiting
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
Tenofovir alafenamide(TAF)
Tenofovir disoproxil fumarate(TDF)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis B focused on measuring Chronic hepatitis B, Efficacy, safety, and tolerability, Tenofovir alafenamide
Eligibility Criteria
Inclusion Criteria:
- Chronic hepatitis B,
- Antiviral experienced,
- Currently on long term TDF anti-HBV treatment,
- HBV DNA < 6 log IU/ml (LLOD)
- Able to sign the consent form of anticipating in the study
Exclusion Criteria:
- Co-infected with HCV, HIV or other viral hepatitis,
- Diagnosis of HCC
Sites / Locations
- Humanity and Health GI and Liver CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TDF switch to TAF
Maintaining on TDF
Arm Description
Tenofovir Disoproxil Fumarate(TDF) 300mg daily switch to Tenofovir Alafenamide(TAF) 25mg daily
Maintaining on Tenofovir Disoproxil Fumarate(TDF) 300mg daily
Outcomes
Primary Outcome Measures
Antiviral response of TAF
Anti-HBV effectiveness of TAF compared with TDF in treatment experienced CHB patients
Secondary Outcome Measures
Improvement of renal function and bone mineral density in CHB patients switching to TAF
Change of renal function and bone mineral density from baseline in CHB patients of TAF a group compared with TDF group
Full Information
NCT ID
NCT03356834
First Posted
September 20, 2017
Last Updated
December 19, 2022
Sponsor
Humanity and Health Research Centre
1. Study Identification
Unique Protocol Identification Number
NCT03356834
Brief Title
Change of Renal Function and Bone Mineral Density in CHB Patients Switch From TDF to TAF vs. Maintaining TDF
Acronym
SWITAF
Official Title
Change of Renal Function and Bone Mineral Density Marker in Chronic Hepatitis B Patients Switching From TDF to TAF vs. Maintaining TDF
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Humanity and Health Research Centre
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
Chronic hepatitis B, Efficacy, safety, and tolerability, Tenofovir alafenamide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TDF switch to TAF
Arm Type
Experimental
Arm Description
Tenofovir Disoproxil Fumarate(TDF) 300mg daily switch to Tenofovir Alafenamide(TAF) 25mg daily
Arm Title
Maintaining on TDF
Arm Type
Active Comparator
Arm Description
Maintaining on Tenofovir Disoproxil Fumarate(TDF) 300mg daily
Intervention Type
Drug
Intervention Name(s)
Tenofovir alafenamide(TAF)
Other Intervention Name(s)
VEMLIDY®
Intervention Description
25 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Tenofovir disoproxil fumarate(TDF)
Other Intervention Name(s)
VIREAD®
Intervention Description
300 mg tablet administered orally once daily
Primary Outcome Measure Information:
Title
Antiviral response of TAF
Description
Anti-HBV effectiveness of TAF compared with TDF in treatment experienced CHB patients
Time Frame
60 months
Secondary Outcome Measure Information:
Title
Improvement of renal function and bone mineral density in CHB patients switching to TAF
Description
Change of renal function and bone mineral density from baseline in CHB patients of TAF a group compared with TDF group
Time Frame
60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic hepatitis B,
Antiviral experienced,
Currently on long term TDF anti-HBV treatment,
HBV DNA < 6 log IU/ml (LLOD)
Able to sign the consent form of anticipating in the study
Exclusion Criteria:
Co-infected with HCV, HIV or other viral hepatitis,
Diagnosis of HCC
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheng Wang, M.D. PhD
Phone
21539831
Email
wangcheng@hnhmgl.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yudong Wang, PhD
Phone
21539831
Email
dannywang@hnhmgl.com
Facility Information:
Facility Name
Humanity and Health GI and Liver Centre
City
Hong Kong
ZIP/Postal Code
00852
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George KK Lau, MD
Phone
(852)28613777
Email
gkklau@netvigator.com
First Name & Middle Initial & Last Name & Degree
Cheng Wang, M.D, PhD
Phone
21539831
Email
wangcheng@hnhmgl.com
First Name & Middle Initial & Last Name & Degree
George KK Lau, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Change of Renal Function and Bone Mineral Density in CHB Patients Switch From TDF to TAF vs. Maintaining TDF
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