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Spots Global Cancer Trial Database for TAF to Prevent HBV Reactivation in Cancer Patients

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: TAF to Prevent HBV Reactivation in Cancer Patients

Official Title: The Efficacy and Safety of TAF as a Prophylactic Antiviral Agent for HBsAg-positive Cancer Patients Receiving Chemotherapy

Study ID: NCT04619082

Study Description

Brief 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. 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.

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Dalin Tzu Chi General Hospital, Chiayi City, , Taiwan

Ditmanson Medical Foundation Chiayi Christian Hospital, Chiayi City, , Taiwan

St. Martin De Porress Hospital, Chiayi City, , Taiwan

Chi Mei Medical Hospital, Tainan, , Taiwan

National Taiwan University Hospital, Yun-Lin Branch, Yun-Lin, , Taiwan

Contact Details

Name: Po-Yueh Chen, MD

Affiliation: Ditmanson Medical Foundation Chiayi Christian Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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