CompletedPhase 4

Prophylactic Use of Entecavir for Non-Hodgkin's Lymphoma Patients With Resolved Hepatitis B

Taiwan80 participantsStarted 2009-04

Plain-language 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 negative for HBsAg have a the risk of HBV reactivation during chemotherapy, but prophylactic antiviral treatment is not a routine by current American Association for the Study of Liver Diseases (AASLD) guideline. Prophylactic entecavir might reduce the risk of HBV reactivation in such patients.

Who can participate

Age range16 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

The primary endpoint is the incidence of HBV reactivation during and within 12 months after chemotherapy

Timeframe: Monthly, and till 12 months after chemotherapy

Trial details

NCT IDNCT00926757

SponsorTaipei Veterans General Hospital, Taiwan

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2012-11

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