Comparison of Prophylactic Antiviral Efficacy in Patients Undergoing Chemotherapy: Entecavir Versus Lamivudine
- Conditions
- Certain infectious and parasitic diseases
- Registration Number
- KCT0000417
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 180
1. HBsAg: positive for at least 6 months
2. Liver status: inactive or active carrier with ALT level < 2xUNL, chronic hepatitis & compensated cirrhosis (Child Pugh class A)
3. Disease and treatment: hematologic (confined to Non-Hodgkin lymphoma) and oncologic (confined to breast, stomach, colorectal, and lung cancer) malignant tumors undergoing adjuvant setting of systemic chemotherapy
4. Informed consent
1. Coinfection status: anti-HCV or anti-HIV positive patients
2. Liver status: Decompensated liver cirrhosis (Child Pugh class B-C) or hepatocellular carcinoma
3. Underlying disease: Patients with an expected survival < 1 year
4. other hematologic malignancies except Non-Hodgkin lymphoma
5. other oncologic malignancies except breast, stomach, colorectal, and lung cancer
6. Patients who had already received antiviral therapy including LAM, ETV or antiviral therapy against HBV infection on the therapeutic purpose within 6 months prior to study entry.
7. Other causes of chronic liver disease except HBV, i.e. seropositive for anti-hepatitis C virus antibody, excessive alcohol consumption (>20 g/day), evidence of autoimmune hepatitis or hemochromatosis
8. Patients who had decompensated liver states such as jaundice, ascites, variceal bleeding, and hepatic encephalopathy as indicated by any one of the following:
- serum bilirubin > 3 mg/dL
- prothrombin time > 4 seconds prolonged or INR >1.7
- serum albumin < 3.0 g/dL
- History of ascites, variceal hemorrhage, or hepatic encephalopathy
- Child-Pugh score =7
9. Patients who have evidence of renal insufficiency defined as serum creatinine > 1.5 mg/dL
10. Patients who received LAM or ETV as deferred treatment of hepatitis flare or acute exacerbation after initiation of chemotherapy
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cumulative probability of HBV reactivation
- Secondary Outcome Measures
Name Time Method Incidence of HBV-related hepatitis flare;The cumulative probability of emergence of genotypic resistance;Incidence of hepatic decompensation and liver-related mortality;Disruptions of chemotherapy due to HBV-related hepatitis