A multicenter open label study to explore the efficacy and tolerability of Tenofovir DF (TDF) (300 mg) in chronic hepatitis B, HBeAg positive or negative, patients with suboptimal response to adefovir (ADV) or ADV/LAM treatment, defined as HBV-DNA levels > 10.000 copies/ml after an ADV or ADV+LAM treatment of > 48 weeks - OptiB: Optimizing treatment for Chronic Hepatitis B patients

• Conditions: Chronic Hepatitis B HBV; MedDRA version: 14.1Level: PTClassification code 10019731Term: Hepatitis BSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2007-001789-34-IT
• Lead Sponsor: AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-04
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

?> 18 years of age
?Chronic HBV infection, defined as positive serum HBsAg for at least 6 months
?Active chronic HBV infection with all the following:
Currently treated with adefovir dipivoxil 10 mg QD or the combination of adefovir dipivoxil 10 mg QD and lamivudine 100 mg QD (for  48 weeks)
HBeAg+ve or anti-HBe+ve at screening
Serum HBV DNA  104 copies/mL
Serum ALT  20  ULN
Hemoglobin  8 g/dL
Neutrophils  750 /mm3
?Adefovir or lamivudine-experienced
?Negative serum -HCG
?Compliant with adefovir dipivoxil
?Willing and able to provide written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

?Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study.
?Male or females of reproductive potential who are unwilling to put into action all necessary steps to avoid pregnancy while enrolled in the study.
?Prior use of tenofovir DF or entecavir
?Received treatment with interferon or pegylated interferon within 6 months of the screening visit.
?Co-infection with HCV (based on serology), HIV, or HDV.
?Significant renal, cardiovascular, pulmonary, or neurological disease.
?Received solid organ or bone marrow transplantation.
?Currently receiving therapy with immunomodulators (e.g., corticosteroids, etc.), investigational agents, nephrotoxic agents, agents capable of modifying renal excretion.
?Proximal tubulopathy
?Known hypersensitivity to the study drugs (tenofovir DF or emtricitabine/tenofovir DF), the metabolites (tenofovir or emtricitabine) or formulation excipients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified