A open-label study of entecavir for chronic hepatitis B to determine the optimum duration of administration

UMIN ID: UMIN000000644

Registered date:01/01/2014

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: chronic hepatitis B
• Date of first enrollment: 2006/12/01
• Target sample size: 70
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

The group of Entecavir administration up to one year after the loss of serum HBV-DNA
The group of Entecavir administration up to two years after the loss of serum HBV-DNA

Outcome(s)

• Primary Outcome: The recurrence rate after completing Entecavir administration, the rate of loss of serum HBV-DNA, the rate of improvement of transaminase, the rate of HBeAg seroconversion

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. During pregnancy and the possibility of pregnancy 2. Participating in the other clinical trials

Related Information

• Primary Sponsor: Gunma Liver Study Group
• Source(s) of Monetary Support: Gunma Liver Study Group