A Randomized Study in Non-Hodgkin's Lymphoma Patients Carrying Hepatitis B Surface Antigen
|ClinicalTrials.gov Identifier: NCT00201318|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : September 20, 2005
* AIMS OF THE STUDY (STUDY OBJECTIVES)
- To test the effect of daily lamivudine (100 mg) in reducing the risk of HBV reactivation and hepatitis development in HBsAg (+) NHL patients.
- To test the efficacy of daily lamivudine in preventing and treating hepatitis B reactivation and in circumventing hepatic failure and death.
- 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.)
|Condition or disease||Intervention/treatment||Phase|
|Non-Hodgkin's Lymphoma||Drug: Cyclophosphamide Doxorubicin Vincristine Lamivudine||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Study of Lamivudine Prophylaxis or Treatment Against Hepatitis B Reactivation in Non-Hodgkin's Lymphoma Patients Carrying Hepatitis B Surface Antigen|
|Study Start Date :||September 2001|
|Estimated Study Completion Date :||October 2005|
- We expect to enter 33 patients per year. Taking into account 10﹪dropout rate, we may finish accrual of patients within 3 years.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00201318
|Mackay Memorial Hospital|
|Study Chair:||Pei-Jer Chen, Ph.D.||National Taiwan University Hospital|
|Study Chair:||Ann-Lii Cheng, Ph.D.||National Taiwan University Hospital|