Overview

Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents With Chronic Hepatitis B

Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gilead Sciences
Treatments:
Adefovir
Adefovir dipivoxil
Lamivudine
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.