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NCT Number: NCT04619082

TAF to Prevent HBV Reactivation in Cancer Patients

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dalin Tzu Chi General Hospital, Chiayi City, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tenofovir alafenamide

Drug

Tenofovir alafenamide 25 mg once per day for one year

Primary outcomes

  1. The rate of HBV reactivation during TAF prophylaxis

    Time frame: after 48 weeks of TAF use

    Definition of HBV reactivation :

    • HBV DNA increase 2 log (100-fold) compared to the baseline level
    • HBV DNA 3 log (1,000) IU/mL in a patient with previously undetectable level
    • HBV DNA 4 log (10,000) IU/mL if the baseline level is not available

Secondary outcomes

  1. The dynamic change of eGFR during TAF prophylaxis

    Time frame: after 48 weeks of TAF use

    record the dynamic change of eGFR from baseline to 48 weeks after TAF

Sponsors and collaborators

Lead sponsor

Chiayi Christian Hospital

Other

Collaborators

  • Chi Mei Medical Hospital
  • Dalin Tzu Chi General Hospital
  • National Taiwan University Hospital, Yun-Lin Branch
  • St. Martin De Porress Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 6, 2020
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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.

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