Status:
COMPLETED
Treatment of Persistent Viremia (Virus in Blood) in Chronic Hepatitis B Subjects Already Receiving Adefovir Dipivoxil
Lead Sponsor:
Gilead Sciences
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-69 years
Phase:
PHASE2
Brief Summary
This study explores the efficacy, safety and tolerability of tenofovir DF (TDF) 300 mg once daily monotherapy versus the combination of emtricitabine 200 mg plus tenofovir DF 300 mg (FTC/TDF) once dai...
Eligibility Criteria
Inclusion
- 18 through 69 years of age, inclusive
- 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 (for at least 24 weeks but not more than 96 weeks)
- HBeAg positive or negative at screening
- Plasma HBV DNA \>/= 1000 copies/mL at screening (irrespective of HBeAg status)
- Serum ALT less than 10 times the upper limit of normal (ULN)
- Calculated creatinine clearance of at least 70 mL/min using the Cockcroft-Gault formula
- Hemoglobin at least 8 g/dL
- Neutrophils at least 1,000 /mm3
- Nucleoside naive except for lamivudine (\>/= 12 weeks of therapy)
- Negative serum beta human chorionic gonadotropin
- Compliant with adefovir dipivoxil
- Willing and able to provide written informed consent
Exclusion
- 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 use an effective method of contraceptive while enrolled in the study. For males, condoms should be used and for females, a barrier contraception method should be used
- Decompensated liver disease defined as conjugated bilirubin greater than 1.5 times ULN, prothrombin time (PT) greater than 1.5 times ULN, platelets less than 75,000/mm3, serum albumin less than 3.0 g/dL, or prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage)
- Prior use of tenofovir DF or entecavir
- Received treatment with interferon or pegylated interferon within 6 months of the screening visit
- Evidence of hepatocellular carcinoma (HCC); for example, alpha-fetoprotein greater than 50 ng/mL or by any other standard of care measure.
- Co-infection with HCV (based on serology), human immunodeficiency virus (HIV), or hepatitis delta virus (HDV)
- Significant renal, cardiovascular, pulmonary, or neurological disease.
- Received solid organ or bone marrow transplantation.
- Is currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion
- Has proximal tubulopathy
- Known hypersensitivity to the study drugs (tenofovir DF or emtricitabine/tenofovir DF), the metabolites (tenofovir or emtricitabine) or formulation excipients
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00307489
Start Date
March 1 2006
End Date
October 1 2010
Last Update
November 1 2011
Active Locations (28)
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1
San Francisco, California, United States, 94115
2
San Jose, California, United States, 95128
3
Flushing, New York, United States, 11355
4
New York, New York, United States, 10013