NCT01438424

Safety and Antiviral Activity of Entecavir in Participants With Chronic Hepatitis B Following Monotherapy in Other Entecavir Trials

A Preliminary Assessment of Safety and Antiviral Activity of Open-label Entecavir in Subjects With Chronic Hepatitis B Following Monotherapy in Other Entecavir Trials

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,053 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to provide entecavir to participants who have completed another entecavir trial without achieving virologic response or who relapsed during postdosing follow-up.

Conditions

• Hepatitis B Virus
• HBV

Interventions

Type	Name	Description
DRUG	Entecavir	Tablets, Oral, 1.0 mg, once daily
DRUG	Lamivudine	Oral, 100 mg, daily

Timeline

• Start date: 2001-01-01
• Primary completion: 2009-12-01
• Completion: 2011-04-01
• First posted: 2011-09-22
• Last updated: 2012-08-23
• Results posted: 2012-08-23