TAF to Prevent HBV Reactivation in Cancer Patients

Phase 4

Active, not recruiting

• Conditions: Hepatitis B Reactivation
• Interventions: Drug: Tenofovir alafenamide

• Registration Number: NCT04619082
• Lead Sponsor: Chiayi Christian Hospital

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.

Study Timeline

• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-06
• Study Start: 2021-07-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-09
• Last Update Posted: 2024-11-12
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAF prophylaxis	Tenofovir alafenamide	Using TAF to prevent HBV reactivation for HBsAg-positive cancer patients

Primary Outcome Measures

Name	Time	Method
The rate of HBV reactivation during TAF prophylaxis	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

Secondary Outcome Measures

Name	Time	Method
The dynamic change of eGFR during TAF prophylaxis	after 48 weeks of TAF use	record the dynamic change of eGFR from baseline to 48 weeks after TAF

Trial Locations

Locations (5)

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