A comparison of lamivudine plus adefovir and entecavir for chronic hepatitis B patients whose HBV DNA levels are below the level of detection by PCR

UMIN ID: UMIN000000898

Registered date:17/11/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chronic hepatitis B
• Date of first enrollment: 2007/11/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Lamivudine/Adefovir group Lamivudine 100mg is administered orally once daily. When resistant virus is appearance or lamivudine is not insufficient, patients are added 10mg of adefovir dipivoxil once daily on lamivudine.
Entecavir group Entecavir 0.5mg is administered orally once daily.

Outcome(s)

• Primary Outcome: an incidence of resistant hepatitis B virus to both LAM and ADV, or ETV at 2 and 5 years
• Secondary Outcome: normalization of the alanine aminotransferase level a reduction in the serum HBV DNA level HBeAg loss and seroconversion an incidence of hepatocellular carcinoma five-year survival

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 nucleoside analogues, malignancy within 5 years, 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, receiving prohibition medication for combination, 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