NCT02081469

Prophylaxis of CHB Patients With Malignant Tumor Receiving Chemotherapy

Phase IV; Different Extend Treatment Duration (6 Months vs 12 Months After Chemotherapy) to Prevent HBV Relapse With Tenofovir for Prophylaxis in Patients With Malignant Tumor Combined With HBV Carrier Receiving Chemotherapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the effectiveness and safety of tenofovir for different treatment duration in preventing HBV relapse in patients with malignancies after receiving chemotherapy and off-treatment of chemotherapy.

Detailed description

This study aims to evaluate the effectiveness and safety of tenofovir in preventing HBV relapse in HBV carriers with malignant tumor following chemotherapy. Approximately 100 patients who are planned to receive chemotherapy for malignant tumor will be invited to participate in this trail. A 1 or less 1-week tenofovir prophylaxis treatment should be administered by all subjects prior to the chemotherapy and eligible subjects will be randomly assigned to extend 24-week prophylaxis group A or 48-week prophylaxis group B in a 1:1 ratio at the end of the chemotherapy. The subjects could be stopped or withdrawn from this study earlier if HBV relapses or need to receive another course of chemotherapy respectively. The relapse episode will be followed until 24 weeks after the end of prophylaxis therapy. Data collection will take place at screening, every cyclic visit of chemotherapy, at the end of chemotherapy, and the following prophylaxis period, then every 4 weeks during the follow-up period. Patients in both groups will be treated with tenofovir or other antiviral agent according to investigator judgement when HBV relapse after discontinuation of tenofovir therapy.

Conditions

• Hepatitis B, Chronic
• Tumor

Interventions

Type	Name	Description
OTHER	TDF	To compare extend TDF 24 wks versus 48 wks prophylaxis efficacy in chemotherapy CHB patients

Timeline

• Start date: 2014-03-17
• Primary completion: 2019-08-05
• Completion: 2019-08-05
• First posted: 2014-03-07
• Last updated: 2020-02-05

Locations

1 site across 1 country: Taiwan