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) compared to placebo following 48 weeks of treatment.

Condition	Treatment or Intervention	Phase
Chronic Hepatitis B	Drug: Adefovir Dipivoxil, 10 mg tablet or oral suspension, 2 mg/mL	Phase III

Further Study Details: 

Primary Outcomes: To investigate the efficacy of adefovir dipivoxil for the treatment of chronic hepatitis B in children and adolescents (age 2 < 18) compared to placebo following 48 weeks of treatment.
Secondary Outcomes: To investigate the safety of adefovir dipivoxil for the treatment of chronic hepatitis B in children and adolescents (age 2 < 18) compared to placebo following 48 weeks of treatment.
Expected Total Enrollment:  150

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) compared to placebo following 48 weeks of treatment. To evaluate the proportion of children and adolescents who experience HBeAg and HBsAg seroconversion following 48 weeks of adefovir dipivoxil or placebo. To evaluate the development of conserved-site mutations associated with resistance to adefovir dipivoxil. To evaluate the long-term safety and efficacy in children and adolescents over an additional 4-year follow-up period including assessment of growth and renal function.

Ages Eligible for Study:  2 Years   -   17 Years,  Genders Eligible for Study:  Both

Criteria

The criteria listed below are only the main inclusion or exclusion criteria (due to limited posting capacity), a complete list will be provided by the study officials.

Key Inclusion Criteria:

• Positive HBsAg equal to or greater than 6 months prior to screening 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.

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.

Karenann Makhuli, Gilead Sciences      919-294-7212    kmakhuli@gilead.com

California
      Gilead Sciences, Inc. 333 Lakeside Drive, Foster City,  California,  94404,  United States; Recruiting

Study ID Numbers:  GS-US-103-0518
Record last reviewed:  March 2005
Last Updated:  March 3, 2005
Record first received:  October 29, 2004
ClinicalTrials.gov Identifier:  NCT00095121
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08