Status:
COMPLETED
Prophylactic Use of Entecavir for Non-Hodgkin's Lymphoma Patients With Resolved Hepatitis B
Lead Sponsor:
Taipei Veterans General Hospital, Taiwan
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Non Hodgkin's Lymphoma
Hepatitis B
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief Summary
Hepatitis B (HBV) reactivation and hepatitis flare induced by cytotoxic chemotherapy is common in cancer patients who have chronic HBV infection. Lymphoma patients who had previous infected by HBV but...
Detailed Description
Hepatitis B (HBV) reactivation and hepatitis flare induced by cytotoxic chemotherapy is common in cancer patients who have chronic HBV infection. It is best characterized in patients with hematologica...
Eligibility Criteria
Inclusion
- CD20 positive lymphoma
- negative for HBsAg and positive for anti-HBc
- age over 16 years old
- alanine aminotransferase less than 2 times the upper limit of normal
- bilirubin \< 2.5 mg/dL
- neutrophil \> 2000/mm3
- platelet \> 100,000/mm3
- creatinine \< 1.5 mg/dL
- urea nitrogen \< 25 mg/dL
- Eastern Cooperative Oncology Group performance score 0 to 2
Exclusion
- Child-Pugh class B or C cirrhosis
- grade 2 or greater heart failure by the NYHA classification
- previous chemotherapy,radiotherapy, or concurrent glucocorticoid therapy for other reasons
- other primary liver diseases, such as chronic hepatitis C, hepatitis D, autoimmune hepatitis, or Wilsons' disease
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00926757
Start Date
April 1 2009
End Date
November 1 2012
Last Update
May 29 2013
Active Locations (1)
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1
Taipei Veterans General Hospital-Division of Gastroenterology, Division of Oncology
Taipei, Taiwan, 11217