A Randomized Study in Non-Hodgkin's Lymphoma Patients Carrying Hepatitis B Surface Antigen
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|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|
|Study Type :||Interventional (Clinical Trial)|
|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|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|