Efficacy of entecavir for chronic hepatitis B patients after curative treatment of hepatocellular carcinoma :randomized controlled trial

Authors
Category Primary study
JournalUMIN Clinical Trials Registry
Year 2008
INTERVENTION: Entecavir group Entecavir 0.5mg is administered orally once daily with conventional treatment (ursodeoxycholic acid, Stronger Neo‐minophagen C (SNMC, a glycyrrhizin preparation), and Shosaiko‐to, etc) non‐Entecavir group conventional treatment only CONDITION: Chronic hepatitis B PRIMARY OUTCOME: the proportion of patients with ; 1.improvement of serum alanine aminotransferase, ALB, T.Bil, PT,; 2.undetectable HBV DNA as measured by PCR assay,; at week 96. SECONDARY OUTCOME: 1.HCC recurrence rates and the period to HCC recurrence; 2.five‐year survival rate INCLUSION CRITERIA: The study is designed to enroll patients with HBsAg positive. Other eligibility criteria includes: Eastern Chemotherapy Oncology Group(ECOG)performance status of 0‐2, curatively treated HCC with RFA, ALT values more than the upper limit of normal(ULN) to 2.5 times the ULN, serum HBV DNA positive (above the cut off value), and no prior therapy of nucleoside analogues. Written informed consent is required from all patients.
Epistemonikos ID: e12463911893f01e0559e616108df1f917c2e938
First added on: Aug 21, 2024