Status:
COMPLETED
Tenofovir Disoproxil Fumarate (Tenofovir DF) Versus Emtricitabine/Tenofovir DF in Subjects Resistant to Lamivudine
Lead Sponsor:
Gilead Sciences
Conditions:
Hepatitis B
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The aim of therapy for the treatment of chronic hepatitis B virus (HBV) is to maintain suppression of viral replication to prevent the emergence of complications, which requires long-term therapy. Dur...
Eligibility Criteria
Inclusion
- 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 IU/mL
- Receiving treatment with 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; adefovir dipivoxil treatment of ≤ 48 weeks at the time of screening (inclusive of combination adefovir dipivoxil + lamivudine at entry) was allowed
- Willing and able to provide written informed consent
- Negative serum pregnancy test (for females of childbearing potential only)
- Calculated creatinine clearance ≥ 50 mL/min
- Hemoglobin ≥ 10 g/dL
- Neutrophils ≥ 1000 /mm\^3
- 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
- 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
- Alanine aminotransferase (ALT) ≥ 10 × the upper limit of the normal range (ULN)
- Decompensated liver disease
- Interferon or pegylated interferon therapy within 6 months of the screening visit
- Alpha fetoprotein \> 50 ng/mL
- Evidence of hepatocellular carcinoma
- Coinfection with hepatitis C virus, HIV, or hepatitis D virus
- Significant renal, cardiovascular, pulmonary, or neurological disease
- Received solid organ or bone marrow transplantation
- Receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion
- Proximal tubulopathy
- Known hypersensitivity to the study drugs, the metabolites or formulation excipients
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT00737568
Start Date
September 1 2008
End Date
February 1 2015
Last Update
March 11 2016
Active Locations (69)
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1
Bradenton, Florida, United States, 34205
2
Flushing, New York, United States, 11355
3
Philadelphia, Pennsylvania, United States, 19107
4
Innsbruck, Austria, A-6020