NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000000884

Registered date:13/11/2007

A comparison of lamivudine plus adefovir and entecavir for chronic hepatitis B patients who had not previously received a nucleoside analogue: A randomized trial

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedChronic hepatitis B
Date of first enrollment2007/07/01
Target sample size200
Countries of recruitmentJapan
Study typeInterventional
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 Outcomean incidence of resistant hepatitis B virus to both LAM and ADV, or ETV at 2 and 5 years
Secondary Outcomenormalization 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 minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaThe 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

Contact

public contact
Name Tadashi Goto
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan Japan
Telephone 03-3815-5411
E-mail tadagotou-gi@umin.ac.jp
Affiliation University of Tokyo Department of Gastroenterology, Faculty of Medicine
scientific contact
Name Haruhiko Yoshida
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan Japan
Telephone 03-3815-5411
E-mail yoshida-2im@h.u-tokyo.ac.jp
Affiliation University of Tokyo Department of Gastroenterology, Faculty of Medicine