TAF to Prevent HBV Reactivation in Cancer Patients

Hepatitis B Reactivation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04619082
• Other study ID #: IRB2020091
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2022
• Source: Chiayi Christian Hospital
• Contact: Po-Yueh Chen, MD
• Phone: +886-5-2765041
• Email: hdilwy7[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis B
• Hepatitis B Reactivation

Intervention

Drug:
• Tenofovir alafenamide
Tenofovir alafenamide 25 mg once per day for one year

Locations

Country	Name	City	State
Taiwan	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

Sponsors (5)

Lead Sponsor	Collaborator
Chiayi Christian Hospital	Chi Mei Medical Hospital, Dalin Tzu Chi General Hospital, National Taiwan University Hospital, Yun-Lin Branch, St. Martin De Porress Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of HBV reactivation during TAF prophylaxis	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	after 48 weeks of TAF use
Secondary	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