Hepatitis BPhase 3NCT03489239
Entecavir to TAF Switch
A Phase 3 study testing Tenofovir Alafenamide in people with Hepatitis B, run by Thomas Jefferson University at 1 site in United States.
Trial summary
A research study to observe the safety, efficacy and tolerability of switching from Entecavir (ETV) to Tenofovir Alafenamide TAF in patients with chronic hepatitis B Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Tenofovir Alafenamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2017to 16 Sep 2020
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects, adult male and female ≥18 years of age with chronic hepatitis B with or without compensated cirrhosis
- Maintained on Entecavir for a minimum of 48 weeks
- Viral suppression (HBV DNA <20 IU/mL) for a minimum of 12 weeks prior to entry are eligible for this study.
- Estimated creatinine clearance ≥ 50 ml/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the baseline evaluation.
Who cannot join
- Subjects with known poor or non-compliance
- Subjects with co-infection with HCV or HIV subjects with decompensated cirrhosis and HCC will be excluded to participate in the study.
- Pregnant women and those who wish to become pregnant during the course of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Long-term Study to Observe Safety and Efficacy of TAF in Patients With Chronic Hepatitis B
A research study to observe the safety, efficacy and tolerability of switching from Entecavir (ETV) to Tenofovir Alafenamide TAF in patients with chronic hepatitis B
- Conditions
- Hepatitis B
- Being tested
- Tenofovir Alafenamide
- 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 AlafenamideDrug
Also called TAF
subjects switching from Entecavir to single arm TAF 25mg
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | SingleArm: TAF 25 mg Receives: Drug: Tenofovir Alafenamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of viral Hepatitis B DNA to be <20 IU/mL
The proportion of subjects with plasma HBV DNA levels below 20 IU/mL at week 48.
Measured: 48 weeks
Secondary outcomes (3)
Complete viral suppression at study completion
The proportion of subjects with complete viral suppression, i.e., plasma HBV DNA level below 20 IU/mL at Week 96.
Measured: 96 Weeks
Positive eGFR changes at study completion compared to Baseline visit
Change in eGFR from baseline to Week 96
Measured: 96 weeks
Improved Bone Mass Density at study completion
% change from baseline in BMD at the hip and lumbar spine at Week 96.
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start16 Nov 2017
- Primary completion15 Aug 2020 (estimated)
- Study completion16 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489239
- Sponsor's protocol ID
- 11729
- Status last verified
- Jun 2020
- First submitted
- 14 Mar 2018
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Study to Observe Safety and Efficacy of TAF in Patients With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT03489239
- Acronym / sponsor ID
- 11729
- Conditions
- Hepatitis B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 15 Aug 2020 (estimated)
- Study completion
- 16 Sep 2020 (estimated)
- First posted
- 5 Apr 2018 (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.
A research study to observe the safety, efficacy and tolerability of switching from Entecavir (ETV) to Tenofovir Alafenamide TAF in patients with chronic hepatitis B
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Tenofovir AlafenamideSingleArm: TAF 25 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects, adult male and female ≥18 years of age with chronic hepatitis B with or without compensated cirrhosis
- Maintained on Entecavir for a minimum of 48 weeks
- Viral suppression (HBV DNA <20 IU/mL) for a minimum of 12 weeks prior to entry are eligible for this study.
- Estimated creatinine clearance ≥ 50 ml/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the baseline evaluation.
Key exclusion criteria (3 listed)
- Subjects with known poor or non-compliance
- Subjects with co-infection with HCV or HIV subjects with decompensated cirrhosis and HCC will be excluded to participate in the study.
- Pregnant women and those who wish to become pregnant during the course of the study.
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 AlafenamideAlso: TAFsubjects switching from Entecavir to single arm TAF 25mg | Drug | Single Arm |
Primary outcome
Results of viral Hepatitis B DNA to be <20 IU/mL
Time frame: 48 weeks
The proportion of subjects with plasma HBV DNA levels below 20 IU/mL at week 48.
3 secondary outcomes
Complete viral suppression at study completion
Time frame: 96 Weeks
Positive eGFR changes at study completion compared to Baseline visit
Time frame: 96 weeks
Improved Bone Mass Density at study completion
Time frame: 96 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
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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 3 study testing Tenofovir Alafenamide in people with Hepatitis B, run by Thomas Jefferson University at 1 site in United States.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2020. 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Results of viral Hepatitis B DNA to be <20 IU/mL (time frame: 48 weeks). 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 25 Jun 2020.