Status:
COMPLETED
Safety and Antiviral Activity of Entecavir in Participants With Chronic Hepatitis B Following Monotherapy in Other Entecavir Trials
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatitis B Virus
HBV
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief 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.
Eligibility 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.
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
1053 Patients enrolled
Trial Details
Trial ID
NCT01438424
Start Date
January 1 2001
End Date
April 1 2011
Last Update
August 23 2012
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