Tenofovir alafenamide
DrugTenofovir alafenamide 25 mg once per day for one year
NCT Number: NCT04619082
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 study is active but is not currently recruiting participants.
Notify Me20 year and older
All sexes
Interventional
Phase 4
Dalin Tzu Chi General Hospital, Chiayi City, Taiwan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Tenofovir alafenamide 25 mg once per day for one year
Time frame: after 48 weeks of TAF use
Definition of HBV reactivation :
Time frame: after 48 weeks of TAF use
record the dynamic change of eGFR from baseline to 48 weeks after TAF
Chiayi Christian Hospital
Other
The Efficacy and Safety of TAF as a Prophylactic Antiviral Agent for HBsAg-positive Cancer Patients Receiving Chemotherapy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04496882
Blood-Borne Infections, Chronic Disease
Chiayi City, Taiwan
View Trial DetailsNCT04942886
Antiviral Drug, HBV
Seoul, South Korea
View Trial DetailsNCT02555943
Chronic Hepatitis C Infection, HBV Coinfection
Hong Kong, China
View Trial Details