Suboptimal Responders to Adefovir Switching to Entecavir

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 4

Conditions

Hepatitis B, Chronic

Treatments

Drug: Entecavir

Drug: Adefovir/Entecavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00718887

AI463-171

Details and patient eligibility

About

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

Enrollment

228 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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.