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Entecavir Prophylaxis in HBsAg+ Lymphoma Patients
NCT01768195Phase 4
Key facts
- Status
- Unknown
- Start
- Jan 2013
- Primary completion
- Dec 2017
- Countries
- 1
- Sponsor
- Peking University
- Modality
- Small Molecules
- Drugs
- entecavir
- Conditions
- hepatitis B (HBV)
01
Overview
Phase 4, open-label, single-arm trial of entecavir in hepatitis B (HBV), sponsored by Peking University. Primary endpoints: Incidence of hepatitis B virus reactivation at 24 months and Incidence of hepatitis B virus reactivation related hepatitis at 24 months. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Entecavir prophylaxis
Single arm receiving entecavir 0.5mg daily during and for 12 months after rituximab-based immunochemotherapy.
03
Who it enrols
Treatment-naive B-cell lymphoma patients who are HBsAg positive and scheduled for rituximab-based immunochemotherapy.
04
Endpoints
Primary
Incidence of hepatitis B virus reactivation
Incidence of hepatitis B virus reactivation related hepatitis
Secondary
Incidence of hepatitis B virus virological response
Incidence of hepatitis B virus serological response
Incidence of hepatitis B virus maintained response
Incidence of hepatitis B virus sustained response
Incidence of hepatitis B virus relapse
Incidence of hepatitis B virus relapse related hepatitis
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