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

UMIN ID: UMIN000001000

Registered date:30/01/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chronic hepatitis B
• Date of first enrollment: 2008/02/01
• Target sample size: 44
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: The exclusion criteria are as follows: a previous history of a severe drug hypersensitivity against an ingredients of Entecavir, extrahepatic metastasis lesion of HCC, malignancy except for HCC (double cancer), severe renal disease (BUN more than 40 mg/dl or creatinine more than 2.0 mg/dl), the presence of other forms of liver disease such as auto immune hepatitis, coinfection with hepatitis C, history of liver transplantation, participation in another clinical trial, and doctors' stop not to register to the study.

Related Information

• Primary Sponsor: University of Tokyo Department of Gastroenterology, Faculty of Medicine
• Source(s) of Monetary Support: None