NCT01914744

Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Reactivation in NHL

Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Virus Reactivation in Patients With Non-Hodgkin Lymphoma on CHOP/R-CHOP: a Randomized Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to prove the superiority of entecavir over lamivudine for preventing the risk of hepatitis B virus reactivation in patients with non-Hodgkin lymphoma on CHOP/R-CHOP.

Detailed description

In china, previous studies showed patients with non-Hodgkin lymphoma (NHL) are likely to have hepatitis B virus (HBV) infection. The risk of HBV reactivation is high when patients were treated with CHOP, especially in combination with rituximab. The aim of this study is to compare entecavir with lamivudine, 2 commonly used anti-virus agents, for preventing the risk of HBV reactivation in patients with NHL on CHOP/R-CHOP.

Conditions

• Non-Hodgkin Lymphoma
• Hepatitis B Reactivation

Interventions

Type	Name	Description
DRUG	Entecavir	entecavir 0.5 mg/day PO
DRUG	Lamivudine	lamivudine 100 mg/day PO

Timeline

• Start date: 2013-02-01
• Primary completion: 2015-12-01
• Completion: 2016-12-01
• First posted: 2013-08-02
• Last updated: 2013-08-02

Locations

1 site across 1 country: China