Chronic Hepatitis BPhase 4SWITAFNCT03356834
Change of Renal Function and Bone Mineral Density in CHB Patients Switch From TDF to TAF vs. Maintaining TDF
A Phase 4 study testing Tenofovir alafenamide(TAF) and Tenofovir disoproxil fumarate(TDF) in people with Chronic Hepatitis B, run by Humanity and Health Research Centre at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Tenofovir alafenamide(TAF) and Tenofovir disoproxil fumarate(TDF)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 575 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2017to 31 Oct 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Co-infected with HCV, HIV or other viral hepatitis,
- Diagnosis of HCC
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Humanity and Health GI and Liver Centre
Hong Kong, Hong Kong, 00852
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Hepatitis B
- Being tested
- Tenofovir alafenamide(TAF), Tenofovir disoproxil fumarate(TDF)
- Keywords
- Chronic hepatitis B, Efficacy, safety, and tolerability, Tenofovir alafenamide
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir alafenamide(TAF)Drug
Also called VEMLIDY®
25 mg tablet administered orally once daily
Tenofovir disoproxil fumarate(TDF)Drug
Also called VIREAD®
300 mg tablet administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| TDF switch to TAF | Experimental | Tenofovir Disoproxil Fumarate(TDF) 300mg daily switch to Tenofovir Alafenamide(TAF) 25mg daily Receives: Drug: Tenofovir alafenamide(TAF) |
| Maintaining on TDF | Active comparator | Maintaining on Tenofovir Disoproxil Fumarate(TDF) 300mg daily Receives: Drug: Tenofovir disoproxil fumarate(TDF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antiviral response of TAF
Anti-HBV effectiveness of TAF compared with TDF in treatment experienced CHB patients
Measured: 60 months
Secondary outcomes (1)
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
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start1 Dec 2017
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 575 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanity and Health Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Lau, Humanity and Health Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356834
- Sponsor's protocol ID
- HumanityHGLC
- Acronym
- SWITAF
- Status last verified
- Mar 2025
- First submitted
- 20 Sep 2017
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change of Renal Function and Bone Mineral Density Marker in Chronic Hepatitis B Patients Switching From TDF to TAF vs. Maintaining TDF
- ClinicalTrials.gov ID
- NCT03356834
- Acronym / sponsor ID
- SWITAF / HumanityHGLC
- Conditions
- Chronic Hepatitis B
- Keywords
- Chronic hepatitis B, Efficacy, safety, and tolerability, Tenofovir alafenamide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 575 participants (actual)
- Lead sponsor
- Humanity and Health Research CentreUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 29 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TDF switch to TAF | Experimental | Drug: Tenofovir alafenamide(TAF)Tenofovir Disoproxil Fumarate(TDF) 300mg daily switch to Tenofovir Alafenamide(TAF) 25mg daily |
| Maintaining on TDF | Active comparator | Drug: Tenofovir disoproxil fumarate(TDF)Maintaining on Tenofovir Disoproxil Fumarate(TDF) 300mg daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Co-infected with HCV, HIV or other viral hepatitis,
- Diagnosis of HCC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir alafenamide(TAF)Also: VEMLIDY®25 mg tablet administered orally once daily | Drug | TDF switch to TAF |
| Tenofovir disoproxil fumarate(TDF)Also: VIREAD®300 mg tablet administered orally once daily | Drug | Maintaining on TDF |
Primary outcome
Antiviral response of TAF
Time frame: 60 months
Anti-HBV effectiveness of TAF compared with TDF in treatment experienced CHB patients
1 secondary outcome
Improvement of renal function and bone mineral density in CHB patients switching to TAF
Time frame: 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tenofovir alafenamide(TAF) and Tenofovir disoproxil fumarate(TDF) in people with Chronic Hepatitis B, run by Humanity and Health Research Centre at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antiviral response of TAF (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.