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

Active Locations (0)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 0 (0 locations)

No Results Found

We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.