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

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Antiviral Agents; Entecavir; Lamivudine

Criteria

Key inclusion criteria:

• Age of 16 years and older

• Receipt of entecavir or lamivudine in a previous entecavir study.

Participants who were, based on their response to entecavir:

• Virologic nonresponders at Week 48

• Partial virologic responders who became nonresponders during the second year of treatment

• Partial virologic responders at Week 96

• Complete responders who relapsed during postdosing follow-up

• Decompensated liver disease in AI463-048 that met 1 or more of the following criteria:

• Nonresponse to adefovir after at least 24 weeks of treatment

• Partial response to adefovir after 96 weeks of treatment

• Complete response to adefovir after relapsing during postdosing follow-up

• Demonstrated intolerance to adefovir

• Except for those participants enrolled from AI463-048, compensated liver disease.

Key exclusion criteria:

• HIV coinfection

• Receiving nephrotoxic or hepatotoxic agents

• Ongoing opportunistic infections

• Hemoglobin level <11.0 g/dL except for those enrolled from AI463-048

• Platelet count <70,000 mm^3 except for those enrolled from AI463-048

• Absolute granulocyte count <1,500 cells/mm^3

• Recent history of pancreatitis (within 24 weeks prior to first dose of therapy)

• Current evidence of ascites requiring paracentesis, hepatic encephalopathy, or variceal bleeding, except for those enrolled from AI463-048

• Known history of allergy to nucleoside analogues.