A Phase 3 Double-Blind, Randomized, Placebo-Controlled Study ofthe Safety and Efficacy of Adefovir Dipivoxil in Children andAdolescents (Age 2 to <18) with Chronic Hepatitis B

Conditions: Chronic Hepatitis B
MedDRA version: 17.1Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2004-001346-33-Outside-EU/EEA

Lead Sponsor: Gilead Sciences Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 173

Inclusion Criteria

- Male or female patients aged 2 to < 18 years.
- Females of childbearing potential must have a negative serum pregnancy test at screening. Females of childbearing potential who are using effective methods of contraception and will agree to continue to do so from 30 days prior to randomization, throughout study medication dosing and for 30 days after the last dose of study medication will be able to participate.
-Documented chronic hepatitis B (positive HBsAg present for = 6 months prior to randomization). HBsAg must be positive at the initial screening visit (i.e., within 4 weeks of first dose) before patients can be enrolled into the study.
- Documented positive HBeAg at screening.
- Serum HBV DNA = 1 × 105 copies/mL (PCR assay) at either the initial or confirmatory screening visits.
Are the trial subjects under 18? yes
Number of subjects for this age range: 173
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol. This would include any active clinically significant renal, cardiac, pulmonary, vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, or malignancy.
- Received immunoglobulins or other immune- or cytokine-based therapies with possible activity against hepatitis B disease within 6 months prior to the initial screening visit.
- Received interferon therapy within 6 months prior to the initial screening visit.
- Received lamivudine therapy within 6 months prior to the initial screening visit.
- Received previous treatment with antiviral agents demonstrating anti-HBV activity other than interferon or lamivudine within 6 months prior to the initial screening visit (e.g., famciclovir, lobucavir, ganciclovir, emtricitabine, amdoxovir, clevudine, entecavir, or others).