Hepatitis BPhase 4NCT02957994
TAF Switch Study in Hepatitis B Monoinfection
A Phase 4 study testing Tenofovir alafenamide fumarate in people with Hepatitis B, run by Asian Pacific Liver Center at Coalition of Inclusive Medicine.
Trial summary
To evaluate various markers of renal function and bone density after the switch to Tenofovir alafenamide fumarate (TAF) in chronic hepatitis B patients who are currently treated with Tenofovir disoproxil fumarate (TDF) . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Tenofovir alafenamide fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 22 Dec 2016to 1 Nov 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic hepatitis B (who are either HBeAg reactive or non-reactive)
- Treated with TDF with unquantifiable Hepatitis B Virus (HBV) DNA by a sensitive Polymerase chain reaction (PCR) assay for a minimum of 6 months
- No prior nucleos(t)ide exposure prior to treatment with TDF
- Treatment with TDF for a minimum of 12 months
Who cannot join
- HIV Infection
About this study
Official title: Analysis of Proximal Renal Tubular Function of "Real World" Chronic Hepatitis B (CHB) Patients Who Are Suppressed on TDF and Switched to TAF
To evaluate various markers of renal function and bone density after the switch to Tenofovir alafenamide fumarate (TAF) in chronic hepatitis B patients who are currently treated with Tenofovir disoproxil fumarate (TDF) .
Read the detailed description
The investigators have previously reported the prevalence of abnormal renal tubular reabsorption of phosphate among CHB patients treated with more than 18 months of TDF to be 48%. Renal tubular dysfunction associated with TDF may be reversible when TDF is discontinued 4. Recently, TAF 25 mg daily was shown to have comparable efficacy to TDF 300 mg with respect to viral suppression in both HBeAg positive and HBeAg negative CHB patients (studies 110 and 108) at 48 weeks of therapy. As speculated, the systemic exposure to tenofovir was significantly less in patients exposed to TAF compared to those on TDF with strikingly less effects noted in a variety of renal and bone parameters for individuals receiving TAF. Notably, however, the question remains to what if any improvements may be seen in CHB patients switched from TDF to TAF.
The investigators propose a prospective open label study to evaluate various markers of renal function and bone density in 80 CHB patients who are currently treated with TDF who are switched to TAF.
- Conditions
- Hepatitis B
- Being tested
- Tenofovir alafenamide fumarate
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir alafenamide fumarateDrug
Also called TAF
Patients on TDF will be switched to TAF
| Study group | Role | What they receive |
|---|---|---|
| TAF Arm | Experimental | Tenofovir alafenamide fumarate 25mg, 1 tablet once daily for 24 weeks Receives: Drug: Tenofovir alafenamide fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure renal function after switch to TAF
Kidney function will be measured by blood and urine to compare abnormal results before and after switching to TAF.
Measured: one year
measure bone density after switch to TAF
Bone density will also be measured to compare T score and Z score before and after switching to TAF
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study start22 Dec 2016
- Primary completion21 Jun 2017
- Study completion1 Nov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asian Pacific Liver Center at Coalition of Inclusive Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Bae, Asian Pacific Liver Center at Coalition of Inclusive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957994
- Sponsor's protocol ID
- IN-US-320-4200
- Status last verified
- Jun 2017
- First submitted
- 24 Oct 2016
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fong TL, Lee BT, Tien A, Chang M, Lim C, Ahn A, Bae HS. Improvement of bone mineral density and markers of proximal renal tubular function in chronic hepatitis B patients switched from tenofovir disoproxil fumarate to tenofovir alafenamide. J Viral Hepat. 2019 May;26(5):561-567. doi: 10.1111/jvh.13053. Epub 2019 Jan 16.
PubMed 30576085
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Proximal Renal Tubular Function of "Real World" Chronic Hepatitis B (CHB) Patients Who Are Suppressed on TDF and Switched to TAF
- ClinicalTrials.gov ID
- NCT02957994
- Acronym / sponsor ID
- IN-US-320-4200
- Conditions
- Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Asian Pacific Liver Center at Coalition of Inclusive MedicineUniversity, hospital or other
- Study start
- 22 Dec 2016 (actual)
- Primary completion
- 21 Jun 2017 (actual)
- Study completion
- 1 Nov 2017 (estimated)
- First posted
- 8 Nov 2016 (estimated)
- 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.
To evaluate various markers of renal function and bone density after the switch to Tenofovir alafenamide fumarate (TAF) in chronic hepatitis B patients who are currently treated with Tenofovir disoproxil fumarate (TDF) .
Detailed description
The investigators have previously reported the prevalence of abnormal renal tubular reabsorption of phosphate among CHB patients treated with more than 18 months of TDF to be 48%. Renal tubular dysfunction associated with TDF may be reversible when TDF is discontinued 4. Recently, TAF 25 mg daily was shown to have comparable efficacy to TDF 300 mg with respect to viral suppression in both HBeAg positive and HBeAg negative CHB patients (studies 110 and 108) at 48 weeks of therapy. As speculated, the systemic exposure to tenofovir was significantly less in patients exposed to TAF compared to those on TDF with strikingly less effects noted in a variety of renal and bone parameters for individuals receiving TAF. Notably, however, the question remains to what if any improvements may be seen in CHB patients switched from TDF to TAF.
The investigators propose a prospective open label study to evaluate various markers of renal function and bone density in 80 CHB patients who are currently treated with TDF who are switched to TAF.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAF Arm | Experimental | Drug: Tenofovir alafenamide fumarateTenofovir alafenamide fumarate 25mg, 1 tablet once daily for 24 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with chronic hepatitis B (who are either HBeAg reactive or non-reactive)
- Treated with TDF with unquantifiable Hepatitis B Virus (HBV) DNA by a sensitive Polymerase chain reaction (PCR) assay for a minimum of 6 months
- No prior nucleos(t)ide exposure prior to treatment with TDF
- Treatment with TDF for a minimum of 12 months
Key exclusion criteria (1 listed)
- HIV Infection
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 fumarateAlso: TAFPatients on TDF will be switched to TAF | Drug | TAF Arm |
Primary outcome
measure renal function after switch to TAF
Time frame: one year
Kidney function will be measured by blood and urine to compare abnormal results before and after switching to TAF.
measure bone density after switch to TAF
Time frame: one year
Bone density will also be measured to compare T score and Z score before and after switching to TAF
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- Derived from this study: PubMed 30576085Fong TL, Lee BT, Tien A, Chang M, Lim C, Ahn A, Bae HS. Improvement of bone mineral density and markers of proximal renal tubular function in chronic hepatitis B patients switched from tenofovir disoproxil fumarate to tenofovir alafenamide. J Viral Hepat. 2019 May;26(5):561-567. doi: 10.1111/jvh.13053. Epub 2019 Jan 16.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tenofovir alafenamide fumarate in people with Hepatitis B, run by Asian Pacific Liver Center at Coalition of Inclusive Medicine.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
measure renal function after switch to TAF (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02957994, which also lists 1 linked publication.
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 29 Jun 2017.