A randomized trial of lamivudine continuous therapy and entecavir switching therapy for chronic hepatitis B patients treated with lamivudine monotherapy

UMIN ID: UMIN000001120

Registered date:16/04/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chronic hepatitis B
• Date of first enrollment: 2008/04/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

LVD group: Lamivudine 100mg is administered orally once daily. When breakthrough hepatitis is developed by resistant virus to LVD, patients are added 10mg of adefovir dipivoxil once daily on lamivudine.
ETV group: ETV 0.5mg is administered orally once daily. When breakthrough hepatitis is developed by resistant virus to ETV, 100mg of lamivudine and 10mg of adefovir dipivoxil once daily are administered.

Outcome(s)

• Primary Outcome: To evaluate the following factors after the two-year therapy by LVD or ETV. 1) An incidence of HBV-DNA negative 2) The rate of ALT normalization 3) An incidence of HBeAg seroconversion 4) An incidence of virological breakthrough 5) An incidence of breakthrough hepatitis
• Secondary Outcome: 1) Existence of resistant HBV to LVD at the entry 2) An incidence of genotypic resistance a. an incidence of resistant HBV to LVD b. an incidence of resistant HBV to ETV 3) HBV genotype 4) HB core related antigen (HBcrAg)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Concomitant medication of nucleoside analogues except for LVD at present. 2) Concomitant medication of IFN. 3) Concomitant medication of immunosuppressant. 4) HBsAb positive patients. 5) Patients with HCC or other malignancy. 6) Patients with decompensated cirrhosis. 7) Pregnant (or possible) women. 8) Patients with under breast feeding. 9) Co-infection with HIV or HCV 10) Other conditions considered inappropriate by attending physician.

Related Information

• Primary Sponsor: Nagoya City University Hospital
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare