Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents With Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Placebo (PLB); Adefovir Dipivoxil (ADV); Lamivudine
Intervention description: Matching placebo; 10-mg tablet or 2-mg/mL oral suspension; 100-mg tablet administered according to package labeling. Lamivudine was to be added to the open-label ADV regimen of subjects with a serum HBV DNA concentration >= 1000 copies/mL at 2 consecutive study visits at or after Study Week 96. If the HBV DNA concentration remained >= 1000 copies/mL at 2 consecutive study visits after the addition of lamivudine, the investigator was required to discontinue all study drugs, perform the early termination ssessments, and have the subject return every 4 weeks for 16 weeks of posttreatment evaluations.
Intervention MeSH terms: Lamivudine; Adefovir; Adefovir dipivoxil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 173.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Hepatitis B; Children; Pediatric; Adefovir Dipivoxil

Summary:

      The purpose of this study is to investigate the efficacy and safety of adefovir dipivoxil for
      the treatment of chronic hepatitis B in children and adolescents (age 2 to less than 18
      years) following 48 weeks of placebo-controlled, double-blind treatment and following an
      additional 192 weeks of open-label adefovir dipivoxil treatment.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Positive HBsAg >= 6 months prior to randomization and positive HBeAg at screening.

          -  Serum HBV DNA greater than or equal to 1 x 100,000 copies/mL (PCR assay) at initial or
             confirmatory screening visit.

          -  Serum ALT levels greater than or equal to 1.5 x ULN at both initial and confirmatory
             screening visits.

          -  Compensated liver disease with anticipated survival greater than 12 months and with
             the following laboratory and clinical parameters within 4 weeks of baseline:
             *Prothrombin time less than or equal to 1 second above normal range. *Total bilirubin
             less than 1.3 mg/dL or normal direct bilirubin. *Serum albumin greater than 3 g/dL
             (greater than 30 g/L). *No clinical history of ascites, variceal bleeding,
             encephalopathy or splenomegaly. *Adequate renal function defined as creatinine
             clearance greater than or equal to 80 mL/min (calculated using Schwartz Formula).

        Key Exclusion Criteria:

          -  Received immunoglobulin, interferon or lamivudine therapy within 6 months prior to
             initial screening visit.

          -  Participated in any investigational trial with any investigational compound within 2
             months prior to initial screening.

          -  Organ or bone marrow transplant recipients.

          -  Clinical evidence of decompensated liver disease.

          -  A Child-Pugh-Turcotte score greater than 6.

          -  Inability to comply with study requirements.