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| Name | Class |
|---|---|
| St. Martin De Porress Hospital | OTHER |
| Dalin Tzu Chi General Hospital | OTHER |
| National Taiwan University Hospital, Yun-Lin Branch | OTHER |
| Chi Mei Medical Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAF prophylaxis | Experimental | Using TAF to prevent HBV reactivation for HBsAg-positive cancer patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir alafenamide | Drug | Tenofovir alafenamide 25 mg once per day for one year |
|
| Measure | Description | Time Frame |
|---|---|---|
| The rate of HBV reactivation during TAF prophylaxis | Definition of HBV reactivation :
| after 48 weeks of TAF use |
| Measure | Description | Time Frame |
|---|---|---|
| The dynamic change of eGFR during TAF prophylaxis | record the dynamic change of eGFR from baseline to 48 weeks after TAF | after 48 weeks of TAF use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Po-Yueh Chen, MD | Ditmanson Medical Foundation Chiayi Christian Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dalin Tzu Chi General Hospital | Chiayi City | 600 | Taiwan | |||
| Ditmanson Medical Foundation Chiayi Christian Hospital |
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| ID | Term |
|---|---|
| C442442 | tenofovir alafenamide |
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| OTHER |
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| Chiayi City |
| 600 |
| Taiwan |
| St. Martin De Porress Hospital | Chiayi City | 600 | Taiwan |
| National Taiwan University Hospital, Yun-Lin Branch | Douliu | Taiwan |
| Chi Mei Medical Hospital | Tainan | Taiwan |