Suboptimal Responders to Adefovir Switching to Entecavir
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: Entecavir; Adefovir/Entecavir
Intervention description: Tablets, Oral, 0.5 mg, once daily (QD), 52 weeks; Tablets, Oral, 10-mg adefovir QD for 12 weeks followed by 0.5-mg entecavir QD for a maximum of 52 weeks
Intervention MeSH terms: Entecavir; Adefovir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 228.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

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

Eligibility 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.