TAF to Prevent HBV Reactivation in Cancer Patients

NCT04619082 | Active Not Recruiting Phase 4

• 1 other identifier: IRB2020091
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 5

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.

Conditions

Hepatitis B Reactivation

Keywords

TAF; cancer patients; chemotherapy

Outcome Measures

Primary Outcomes (1)

• The rate of HBV reactivation during TAF prophylaxis

  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

  after 48 weeks of TAF use

Secondary Outcomes (1)

• The dynamic change of eGFR during TAF prophylaxis

  after 48 weeks of TAF use

Study Arms (1)

TAF prophylaxis

EXPERIMENTAL

Using TAF to prevent HBV reactivation for HBsAg-positive cancer patients

Drug: Tenofovir alafenamide

Interventions

Tenofovir alafenamide DRUG

Tenofovir alafenamide 25 mg once per day for one year

TAF prophylaxis

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (5)

Dalin Tzu Chi General Hospital

Chiayi City, 600, Taiwan

Location

Ditmanson Medical Foundation Chiayi Christian Hospital

Chiayi City, 600, Taiwan

Location

St. Martin De Porress Hospital

Chiayi City, 600, Taiwan

Location

National Taiwan University Hospital, Yun-Lin Branch

Douliu, Taiwan

Location

Chi Mei Medical Hospital

Tainan, Taiwan

Location

MeSH Terms

Interventions

tenofovir alafenamide

Study Officials

• Po-Yueh Chen, MD

  Ditmanson Medical Foundation Chiayi Christian Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 6, 2020
• Study Start: July 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (5)