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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Hepatitis B Virus; HBV

Treatments: Drug: Entecavir; Drug: Lamivudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01438424

AI463-901

Details and patient eligibility

About

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.

Enrollment: 1,053 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,053 participants in 1 patient group

Entecavir, 1.0 mg, with or without lamivudine

Experimental group

Treatment:

Drug: Entecavir

Drug: Lamivudine