An investigation of the effectiveness and safety of Tenofovir DisoproxilFumarate (TDF) given on its own versus Emtricitabine and TDF takentogether in patients with long lasting Hepatitis B for whom lamivudinetherapy has not been successful due to the virus becoming resistant toits actio

• Conditions: Chronic Hepatitis B; MedDRA version: 14.1Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2008-001464-36-BG
• Lead Sponsor: Gilead Science Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-27
• Last Update Posted: 25 January 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Chronic HBV infection, defined as positive serum HBsAg for at least 6 months
• 18 through 75 years of age, inclusive
• HBV DNA = 10^3 copies/mL
• Currently receiving lamivudine with confirmation of HBV reverse transcriptase mutation(s) known to confer resistance to lamivudine (rtM204I/V with or without rtL180M) by central laboratory assessment prior to randomization.
• Prior or current adefovir dipivoxil treatment of = 48 weeks at the time of screening (inclusive of combination adefovir dipivoxil + lamivudine at entry) is allowed
• Willing and able to provide written informed consent
• Negative serum ß-HCG (for females of childbearing potential only)
• Calculated creatinine clearance = 50 mL/min
• Hemoglobin = 10 g/dL
• Neutrophils = 1000 /mm3
• No prior oral HBV therapy with approved nucleotide and/or nucleoside therapy or other investigational agents for HBV infection other than lamivudine or adefovir dipivoxil.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 239
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 41

Exclusion Criteria

• Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study.
• Males and females of reproductive potential who are not willing to use an effective” method of contraception during the study. For males, condoms should be used and for females, a barrier contraception method should be used in combination with one other form of contraception.
• ALT = 10 × ULN
• Decompensated liver disease defined as direct (conjugated) bilirubin > 1.5 x ULN, prothrombin time (PT) > 1.5 x ULN, platelets < 75,000/mm3, serum albumin < 3.0 g/dL, or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy, variceal hemorrhage).
• Received interferon (pegylated or not) therapy within 6 months of the screening visit
• a -fetoprotein > 50 ng/mL
• Evidence of HCC
• Co infection with HCV (by serology), HIV, or HDV
• Significant renal, cardiovascular, pulmonary, or neurological disease
• Received solid organ or bone marrow transplantation
• Is currently receiving therapy with immunomodulators (e.g., corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion
• Has proximal tubulopathy
• Known hypersensitivity to the study drugs, the metabolites or formulation excipients

Study & Design

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