Suboptimal Responders to Adefovir Switching to Entecavir

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

Summary

Switching to Entecavir will result in superior antiviral efficacy as compared to continuing with Adefovir in patients with a suboptimal response to Adefovir

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Adefovir; Adefovir dipivoxil; Entecavir

Criteria

Inclusion Criteria:

• Chronic infection with hepatitis B virus (HBV)(detectable hepatitis B surface antibody (HBsAg) at screening and at least 24 weeks prior to screening, or detectable HBsAg for <24 weeks and negative for immunoglobulin M core antibody)

• Documentation of hepatitis B e antigen (HBeAg) positive or negative status

• Naive to nucleoside/nucleotide analogues, with the exception of adefovir

• Suboptimal response to adefovir treatment

• No lamivudine/telbivudine, entecavir, or adefovir resistance-associated substitutions at screening

• Male or female gender, aged 16 years and older

• Compensated liver function

• Serum alanine aminotransferase level <10*upper limit of normal at screening

Exclusion Criteria:

• Women who are pregnant or breastfeeding

• Evidence of decompensated cirrhosis

• Coinfection with HIV, hepatitis C virus, or hepatitis D virus

• Recent history of pancreatitis (within 24 weeks prior to the first dose of study medication)

• Chronic renal insufficiency, defined as a creatinine clearance <50 mL/min

• Current abuse of illegal drugs or alcohol, sufficient in the investigator's opinion to prevent adequate compliance with study therapy or to increase the risk of hepatotoxicity or pancreatitis

• Other serious medical conditions that might preclude completion of this study or that require chronic administration of prohibited medications

• Serum creatinine level >1.5 mg/dL; hemoglobin level <10.0 g/dL; platelet count <70,000/mm^3; absolute neutrophil count <1500 cells/mm^3; serum alpha fetoprotein level >100 ng/mL

• Except adefovir, any prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B (eg, lamivudine, entecavir), or any other experimental anti-HBV antiviral, or any China Traditional Medicine

• Therapy with interferon, thymosin alpha, or other immunostimulators within 24 weeks of randomization

• Required chronic administration of medications that cause immunosuppression, that are associated with a high risk of nephrotoxicity or hepatotoxicity, or that affect renal excretion.