Status:
COMPLETED
Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents With Chronic Hepatitis B
Lead Sponsor:
Gilead Sciences
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
Brief 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 4...
Detailed Description
Weeks 1 through 48 (Study Year 1): The first 48 weeks of the study were a randomized, double-blind, placebo-controlled, parallel-group treatment period. Participants were randomly assigned to treatmen...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT00095121
Start Date
June 1 2004
End Date
April 1 2010
Last Update
May 22 2012
Active Locations (1)
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1
Boston, Massachusetts, United States