Hepatitis B, ChronicPhase 4NCT02081469
Prophylaxis of CHB Patients With Malignant Tumor Receiving Chemotherapy
A Phase 4 study testing TDF in people with Hepatitis B, Chronic and Tumor, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
To evaluate the effectiveness and safety of tenofovir for different treatment duration in preventing HBV relapse in patients with malignancies after receiving chemotherapy and off-treatment of chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis B, Chronic, Tumor
- What is being tested?
- TDF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Mar 2014to 5 Aug 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18 to 70 years of age
- Patients with histologically proven malignant tumor planned to receive chemotherapy after enrollment
- Hepatitis B virus (HBV) carriers who fulfill one of the following criteria:
- seropositive of HBsAg, or HBsAg negative, but Anti-HBc positive with HBV DNA detectable defined as HBV DNA > 20 IU/mL (by Roche Taqman real time assay).
- Patients with ALT ≤ 2 x ULN (upper limit of normal)
- Normal Cr mg/dL or eGFR > 80 mL/min
- Life expectancy > 1 year
- Willing and able to provide written informed consent
Who cannot join
- Females who are pregnant/nursing or with intention to be pregnant within the study period
- Documented hepatitis C virus (HCV) co-infection
- Patients with other current major systemic disease such as active infection, significant cardiac disease, poor control diabetes mellitus, osteopenia or osteoporosis that the investigators consider to be significant risk
- Current use of any hepatitis B prophylaxis medication
- Decompensated liver cirrhosis
- Current or previous use of any chemotherapy
- Use of any investigational product medicine within 1 month prior to the initiation of study treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV; Different Extend Treatment Duration (6 Months vs 12 Months After Chemotherapy) to Prevent HBV Relapse With Tenofovir for Prophylaxis in Patients With Malignant Tumor Combined With HBV Carrier Receiving Chemotherapy
To evaluate the effectiveness and safety of tenofovir for different treatment duration in preventing HBV relapse in patients with malignancies after receiving chemotherapy and off-treatment of chemotherapy.
Read the detailed description
This study aims to evaluate the effectiveness and safety of tenofovir in preventing HBV relapse in HBV carriers with malignant tumor following chemotherapy. Approximately 100 patients who are planned to receive chemotherapy for malignant tumor will be invited to participate in this trail. A 1 or less 1-week tenofovir prophylaxis treatment should be administered by all subjects prior to the chemotherapy and eligible subjects will be randomly assigned to extend 24-week prophylaxis group A or 48-week prophylaxis group B in a 1:1 ratio at the end of the chemotherapy. The subjects could be stopped or withdrawn from this study earlier if HBV relapses or need to receive another course of chemotherapy respectively. The relapse episode will be followed until 24 weeks after the end of prophylaxis therapy. Data collection will take place at screening, every cyclic visit of chemotherapy, at the end of chemotherapy, and the following prophylaxis period, then every 4 weeks during the follow-up period. Patients in both groups will be treated with tenofovir or other antiviral agent according to investigator judgement when HBV relapse after discontinuation of tenofovir therapy.
- Conditions
- Hepatitis B, Chronic, Tumor
- Being tested
- TDF
- Keywords
- Chronic hepatitis B, HBV, Chemotherapy, Reactivation, Prophylaxis
- Medical subject headings
- Hepatitis B, Chronic, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDFOther
Also called viread
To compare extend TDF 24 wks versus 48 wks prophylaxis efficacy in chemotherapy CHB patients
| Study group | Role | What they receive |
|---|---|---|
| Arm A:TDF for extend 24 weeks | Other | Arm A:Continue TDF 300mg daily for extend 24 weeks after completion of chemotherapy Receives: Other: TDF |
| Arm B: TDF for extend 48 weeks | Other | Arm B: Continue TDF 300mg daily for extend 48 weeks after completion of chemotherapy. Receives: Other: TDF |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the HBV relapse rate during the follow-up period in HBV carriers with malignant tumor receiving tenofovir for 24 and 48 weeks after the end of chemotherapy.
To compare the HBV relapse rate during the follow-up period in HBV carriers with malignant tumor receiving tenofovir for 24 and 48 weeks after the end of chemotherapy.
- HBV relapse is defined as: acute liver flare, i.e. ALT ≥ 2 x ULN and HBV DNA > 2000 IU/mL.
Measured: 24 to 48 weeks
Secondary outcomes (1)
To estimate the efficacy of TDF during chemotherapy with after chemotherapy and post-chemotherapy,as measure by the HBV reactivation, clinical relapse and adverse events in all patients.
AST, ALT, Bil(T), Cr (eGFR or MDRD), phosphate, urine analysis, HBsAgQT and HBV DNA were measured at baseline, every 2 cycle of chemotherapy, the end of chemotherapy, the end of TDF and the end of complete follow-up (after the end of TDF for 6 months).
Measured: The efficacy of TDF duration 24 wks versus 48 wks extended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study start17 Mar 2014
- Primary completion5 Aug 2019
- Study completion5 Aug 2019
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 B, ChronicStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Tenofovir 300mg QD. Two arm: 6 month and 12 month.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Chao-Wei Hsu, Chang Gung Memorial Hospital
- Investigators
- Chao-Wei Hsu, MD, Principal investigator, Chang Gung Medical Foundation (Linkou Branch)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081469
- Sponsor's protocol ID
- IN-US-174-0207
- Status last verified
- Jan 2020
- First submitted
- 4 Mar 2014
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hsu CW, Chen SC, Wang PN, Wang HM, Chen YC, Yeh CT. Preventing viral relapse with prophylactic tenofovir in hepatitis B carriers receiving chemotherapy: a phase IV randomized study in Taiwan. Hepatol Int. 2024 Apr;18(2):449-460. doi: 10.1007/s12072-023-10635-5. Epub 2024 Feb 20.
PubMed 38376651
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV; Different Extend Treatment Duration (6 Months vs 12 Months After Chemotherapy) to Prevent HBV Relapse With Tenofovir for Prophylaxis in Patients With Malignant Tumor Combined With HBV Carrier Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT02081469
- Acronym / sponsor ID
- IN-US-174-0207
- Conditions
- Hepatitis B, Chronic, Tumor
- Keywords
- Chronic hepatitis B, HBV, Chemotherapy, Reactivation, Prophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 17 Mar 2014 (actual)
- Primary completion
- 5 Aug 2019 (actual)
- Study completion
- 5 Aug 2019 (actual)
- First posted
- 7 Mar 2014 (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 the effectiveness and safety of tenofovir for different treatment duration in preventing HBV relapse in patients with malignancies after receiving chemotherapy and off-treatment of chemotherapy.
Detailed description
This study aims to evaluate the effectiveness and safety of tenofovir in preventing HBV relapse in HBV carriers with malignant tumor following chemotherapy. Approximately 100 patients who are planned to receive chemotherapy for malignant tumor will be invited to participate in this trail. A 1 or less 1-week tenofovir prophylaxis treatment should be administered by all subjects prior to the chemotherapy and eligible subjects will be randomly assigned to extend 24-week prophylaxis group A or 48-week prophylaxis group B in a 1:1 ratio at the end of the chemotherapy. The subjects could be stopped or withdrawn from this study earlier if HBV relapses or need to receive another course of chemotherapy respectively. The relapse episode will be followed until 24 weeks after the end of prophylaxis therapy. Data collection will take place at screening, every cyclic visit of chemotherapy, at the end of chemotherapy, and the following prophylaxis period, then every 4 weeks during the follow-up period. Patients in both groups will be treated with tenofovir or other antiviral agent according to investigator judgement when HBV relapse after discontinuation of tenofovir therapy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Tenofovir 300mg QD. Two arm: 6 month and 12 month.
| Arm | Type | Receives |
|---|---|---|
| Arm A:TDF for extend 24 weeks | Other | Other: TDFArm A:Continue TDF 300mg daily for extend 24 weeks after completion of chemotherapy |
| Arm B: TDF for extend 48 weeks | Other | Other: TDFArm B: Continue TDF 300mg daily for extend 48 weeks after completion of chemotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female 18 to 70 years of age
- Patients with histologically proven malignant tumor planned to receive chemotherapy after enrollment
- Hepatitis B virus (HBV) carriers who fulfill one of the following criteria:
- seropositive of HBsAg, or HBsAg negative, but Anti-HBc positive with HBV DNA detectable defined as HBV DNA > 20 IU/mL (by Roche Taqman real time assay).
- Patients with ALT ≤ 2 x ULN (upper limit of normal)
Key exclusion criteria (7 listed)
- Females who are pregnant/nursing or with intention to be pregnant within the study period
- Documented hepatitis C virus (HCV) co-infection
- Patients with other current major systemic disease such as active infection, significant cardiac disease, poor control diabetes mellitus, osteopenia or osteoporosis that the investigators consider to be significant risk
- Current use of any hepatitis B prophylaxis medication
- Decompensated liver cirrhosis
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 |
|---|---|---|
| TDFAlso: vireadTo compare extend TDF 24 wks versus 48 wks prophylaxis efficacy in chemotherapy CHB patients | Other | Arm A:TDF for extend 24 weeks, Arm B: TDF for extend 48 weeks |
Primary outcome
To compare the HBV relapse rate during the follow-up period in HBV carriers with malignant tumor receiving tenofovir for 24 and 48 weeks after the end of chemotherapy.
Time frame: 24 to 48 weeks
To compare the HBV relapse rate during the follow-up period in HBV carriers with malignant tumor receiving tenofovir for 24 and 48 weeks after the end of chemotherapy. * HBV relapse is defined as: acute liver flare, i.e. ALT ≥ 2 x ULN and HBV DNA > 2000 IU/mL.
1 secondary outcome
To estimate the efficacy of TDF during chemotherapy with after chemotherapy and post-chemotherapy,as measure by the HBV reactivation, clinical relapse and adverse events in all patients.
Time frame: The efficacy of TDF duration 24 wks versus 48 wks extended
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 5 Feb 2020.
- Derived from this study: PubMed 38376651Hsu CW, Chen SC, Wang PN, Wang HM, Chen YC, Yeh CT. Preventing viral relapse with prophylactic tenofovir in hepatitis B carriers receiving chemotherapy: a phase IV randomized study in Taiwan. Hepatol Int. 2024 Apr;18(2):449-460. doi: 10.1007/s12072-023-10635-5. Epub 2024 Feb 20.
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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.
Chao-Wei Hsu, MD principal investigator
Chang Gung Medical Foundation (Linkou Branch)
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 TDF in people with Hepatitis B, Chronic and Tumor, run by Chang Gung Memorial Hospital at 1 site 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 8 inclusion and 7 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 5 Feb 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 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?
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?
To compare the HBV relapse rate during the follow-up period in HBV carriers with malignant tumor receiving tenofovir for 24 and 48 weeks after the end of chemotherapy. (time frame: 24 to 48 weeks). 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 NCT02081469, 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 5 Feb 2020.