A Randomized Study in Non-Hodgkin's Lymphoma Patients Carrying Hepatitis B Surface Antigen
Status:
Completed
Trial end date:
2005-10-01
Target enrollment:
Participant gender:
Summary
* AIMS OF THE STUDY (STUDY OBJECTIVES)
1. To test the effect of daily lamivudine (100 mg) in reducing the risk of HBV reactivation
and hepatitis development in HBsAg (+) NHL patients.
2. To test the efficacy of daily lamivudine in preventing and treating hepatitis B
reactivation and in circumventing hepatic failure and death.
3. To test whether lamivudine can improve the overall outcome of NHL patients who are HBV
carriers.
(Study end-points: The major end-point: hepatitis B reactivation in NHL patients---defined by
higher than 10-fold increase of serum HBV DNA level and/or reappearance of HBeAg in the serum
during and within 6 months after chemotherapy. The minor end-point I : events of hepatic
failure and death---defined by jaundice with hepatic encephalopathy. The minor end-point II:
the response rate and survival rate in HBsAg-positive NHL patients receiving lamivudine
prophylaxis and treatment.)
Phase:
Phase 2
Details
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborators:
Chi Mei Medical Hospital Mackay Memorial Hospital National Cheng-Kung University Hospital National Taiwan University Hospital Taipei Veterans General Hospital, Taiwan