Hepatitis B ReactivationPhase 4NCT04619082
TAF to Prevent HBV Reactivation in Cancer Patients
A Phase 4 study testing Tenofovir alafenamide in people with Hepatitis B Reactivation, run by Chiayi Christian Hospital at 5 sites in Taiwan.
Trial summary
Tenofovir alafenamide (TAF) has been approved to prevent HBV reactivation for HBsAg-positive cancer patients receiving chemotherapy. However, the real-world effectiveness and safety of TAF for cancer patients was lacing. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatitis B Reactivation
- What is being tested?
- Tenofovir alafenamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 5 sitesTaiwan
- Study dates
- 1 Jul 2021to 31 Dec 2024
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age ≥20) with positive HBsAg who are prepared to receive systemic chemotherapy
- The presence of HBs antigen should be confirmed within recent two years
- The patients who could receive systemic chemotherapy in 4 weeks
Who cannot join
- Patients with poor performance status (Zubrod-ECOG ≥ 2 or Karnofsky score ≤ 70)
- Patients with cirrhosis
- Patients had eGFR lower than 15 ml/min/1.73m2 and didn't receive dialysis
- Patients had exposure to any NUC or interferon within 6 months before chemotherapy
- Patients were co-infected with HCV or HIV
- Allergy history to any tenofovir-based medication
- Pregnant woman
- Unable to sign inform consent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Taiwan5 sites
Dalin Tzu Chi General Hospital
Chiayi City, 600
Ditmanson Medical Foundation Chiayi Christian Hospital
Chiayi City, 600
St. Martin De Porress Hospital
Chiayi City, 600
National Taiwan University Hospital, Yun-Lin Branch
Douliu
Chi Mei Medical Hospital
Tainan
About this study
Official title: The Efficacy and Safety of TAF as a Prophylactic Antiviral Agent for HBsAg-positive Cancer Patients Receiving Chemotherapy
Tenofovir alafenamide (TAF) has been approved to prevent HBV reactivation for HBsAg-positive cancer patients receiving chemotherapy. However, the real-world effectiveness and safety of TAF for cancer patients was lacing. Therefore, we conduct a prospective single arm study to evaluate the efficacy and safety of TAF as a prophylactic antiviral agent for HBsAg-positive cancer patients receiving chemotherapy.
Read the detailed description
This prospective single arm study would be conducted in Taiwan. Patients who fulfill the inclusion criteria, will receive TAF before the initiation of systemic chemotherapy. Based on the guidance of NHI in Taiwan, prophylactic anti-viral agent should be prescribed within 7 days before chemotherapy and would be discontinued at 6 months after cessation of chemotherapy. The duration of TAF prophylaxis would be followed the guidance of NHI in Taiwan, however, the end of our observation would be at week 48 after TAF use. Patients will receive regular follow up at week 4, 12, 24, 36 and 48 (for T-bil, AST, ALT, creatinine, HBsAg, HBV DNA) till 1 year and the outcome will be collected. Platelet and HBcrAg would be examined at enrollment, 24 weeks and 48 weeks. HBeAg and anti-HBeAg will be examined at enrollment and 48 weeks.
- Conditions
- Hepatitis B Reactivation
- Being tested
- Tenofovir alafenamide
- Keywords
- TAF, cancer patients, chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir alafenamideDrug
Tenofovir alafenamide 25 mg once per day for one year
| Study group | Role | What they receive |
|---|---|---|
| TAF prophylaxis | Experimental | Using TAF to prevent HBV reactivation for HBsAg-positive cancer patients Receives: Drug: Tenofovir alafenamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of HBV reactivation during TAF prophylaxis
Definition of HBV reactivation :
- HBV DNA increase 2 log (100-fold) compared to the baseline level
- HBV DNA 3 log (1,000) IU/mL in a patient with previously undetectable level
- HBV DNA 4 log (10,000) IU/mL if the baseline level is not available
Measured: after 48 weeks of TAF use
Secondary outcomes (1)
The dynamic change of eGFR during TAF prophylaxis
record the dynamic change of eGFR from baseline to 48 weeks after TAF
Measured: after 48 weeks of TAF use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Jul 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B ReactivationStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiayi Christian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Martin De Porress Hospital, Dalin Tzu Chi General Hospital, National Taiwan University Hospital, Yun-Lin Branch, Chi Mei Medical Hospital
- Responsible party
- Sponsor
- Investigators
- Po-Yueh Chen, MD, Principal investigator, Ditmanson Medical Foundation Chiayi Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619082
- Sponsor's protocol ID
- IRB2020091
- Status last verified
- Nov 2024
- First submitted
- 2 Nov 2020
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of TAF as a Prophylactic Antiviral Agent for HBsAg-positive Cancer Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT04619082
- Acronym / sponsor ID
- IRB2020091
- Conditions
- Hepatitis B Reactivation
- Keywords
- TAF, cancer patients, chemotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Chiayi Christian HospitalUniversity, hospital or other
- Collaborators
- St. Martin De Porress Hospital, Dalin Tzu Chi General Hospital, National Taiwan University Hospital, Yun-Lin Branch, Chi Mei Medical Hospital
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Nov 2020 (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.
Tenofovir alafenamide (TAF) has been approved to prevent HBV reactivation for HBsAg-positive cancer patients receiving chemotherapy. However, the real-world effectiveness and safety of TAF for cancer patients was lacing. Therefore, we conduct a prospective single arm study to evaluate the efficacy and safety of TAF as a prophylactic antiviral agent for HBsAg-positive cancer patients receiving chemotherapy.
Detailed description
This prospective single arm study would be conducted in Taiwan. Patients who fulfill the inclusion criteria, will receive TAF before the initiation of systemic chemotherapy. Based on the guidance of NHI in Taiwan, prophylactic anti-viral agent should be prescribed within 7 days before chemotherapy and would be discontinued at 6 months after cessation of chemotherapy. The duration of TAF prophylaxis would be followed the guidance of NHI in Taiwan, however, the end of our observation would be at week 48 after TAF use. Patients will receive regular follow up at week 4, 12, 24, 36 and 48 (for T-bil, AST, ALT, creatinine, HBsAg, HBV DNA) till 1 year and the outcome will be collected. Platelet and HBcrAg would be examined at enrollment, 24 weeks and 48 weeks. HBeAg and anti-HBeAg will be examined at enrollment and 48 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAF prophylaxis | Experimental | Drug: Tenofovir alafenamideUsing TAF to prevent HBV reactivation for HBsAg-positive cancer patients |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (age ≥20) with positive HBsAg who are prepared to receive systemic chemotherapy
- The presence of HBs antigen should be confirmed within recent two years
- The patients who could receive systemic chemotherapy in 4 weeks
Key exclusion criteria (8 listed)
- Patients with poor performance status (Zubrod-ECOG ≥ 2 or Karnofsky score ≤ 70)
- Patients with cirrhosis
- Patients had eGFR lower than 15 ml/min/1.73m2 and didn't receive dialysis
- Patients had exposure to any NUC or interferon within 6 months before chemotherapy
- Patients were co-infected with HCV or HIV
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 alafenamideTenofovir alafenamide 25 mg once per day for one year | Drug | TAF prophylaxis |
Primary outcome
The rate of HBV reactivation during TAF prophylaxis
Time frame: after 48 weeks of TAF use
Definition of HBV reactivation : 1. HBV DNA increase 2 log (100-fold) compared to the baseline level 2. HBV DNA 3 log (1,000) IU/mL in a patient with previously undetectable level 3. HBV DNA 4 log (10,000) IU/mL if the baseline level is not available
1 secondary outcome
The dynamic change of eGFR during TAF prophylaxis
Time frame: after 48 weeks of TAF use
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 12 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Hepatitis B Reactivation
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HBV Reactivation Prediction Model in Allo-HSCT
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Entecavir Prophylaxis for Hepatitis B Reactivation for CD20 Positive B-cell Lymphoma Patients With Resolved Hepatitis B (Negative Hepatitis B Surface Antigen, Positive Hepatitis B Core Antibody)
Resolved Hepatitis B, CD20 Positive B-cell Lymphoma
Active, not recruitingPhase 4
Chronic Hepatitis b Patients Switch to tAf After Discontinuation of Nucleoside Analogue
Chronic Hepatitis b, Hepatitis B Reactivation
Active, not recruitingObservational study
Risk of Reactivation of Occult Hepatitis B in Cancer Patients During Immunotherapy.
Occult Hepatitis B Infection in Cancer Patients
Enrolling by invitation
Prophylactic Entecavir for HBV Reactivation in Past HBV Infected Patients With Hematopoietic Stem Cell Transplantation
Hepatitis B Reactivation, Hematopoietic Stem Cell Transplantation
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.
Po-Yueh Chen, MD principal investigator
Ditmanson Medical Foundation Chiayi Christian Hospital
5 sites 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 in people with Hepatitis B Reactivation, run by Chiayi Christian Hospital at 5 sites in Taiwan.
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 3 inclusion and 8 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 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan. 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?
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?
The rate of HBV reactivation during TAF prophylaxis (time frame: after 48 weeks of TAF use). 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 12 Nov 2024.