Status:
COMPLETED
A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Positive Chronic Hepatitis B
Lead Sponsor:
Gilead Sciences
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-69 years
Phase:
PHASE3
Brief Summary
The primary objectives of this study are to compare the efficacy, safety, and tolerability of tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of HBeAg-positive ch...
Eligibility Criteria
Inclusion
- Key
- A patient must meet all of the following inclusion criteria to be eligible for participation in this study:
- Chronic hepatitis B virus (HBV) infection, defined as positive serum hepatitis B s-antigen (HBsAg) for more than 6 months
- 18 through 69 years of age, inclusive
- Active hepatitis B e-antigen (HBeAg) positive chronic HBV infection, with all of the following:
- HBeAg positive at screening
- Alanine aminotransferase (ALT) levels \> 2 × ULN and ≤ 10 × the upper limit of the normal range (ULN)
- Serum HBV DNA \> 1 million copies/mL at screening
- creatinine clearance ≥ 70 mL/min
- hemoglobin ≥ 8 g/dL
- neutrophils ≥ 1,000 /mL
- Knodell necroinflammatory score ≥ 3 and a Knodell fibrosis score \< 4; however, up to 96 patients with cirrhosis, ie, a Knodell fibrosis score equal to 4, will be eligible for enrollment
- Negative serum β-human chorionic gonadotropin (hCG)
- Nucleotide naïve, ie, no prior nucleotide (TDF or ADV) therapy for \> 12 weeks
- Nucleoside naïve, ie, no prior nucleoside (any nucleoside) therapy for \> 12 weeks
- Willing and able to provide written informed consent
- Liver biopsy performed within 6 months of baseline and has readable biopsy slides or agrees to have a biopsy performed prior to baseline
- Key
Exclusion
- A patient who meets any of the following exclusion criteria is not to be enrolled in this study:
- 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 unwilling 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
- Decompensated liver disease defined as conjugated bilirubin \> 1.5 x ULN, prothrombin time (PT) \> 1.5 x ULN, platelets \< 75,000/mL, serum albumin \< 3.0 g/dL, or prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage)
- Received any nucleoside, nucleotide (TDF or ADV) or interferon (pegylated or not) therapy within 6 months prior to the pre-treatment biopsy
- Evidence of hepatocellular carcinoma (HCC), ie, α-fetoprotein \>50 ng/mL
- Coinfection with hepatitis C virus (HCV), 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 susceptible of modifying renal excretion
- Has proximal tubulopathy
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
266 Patients enrolled
Trial Details
Trial ID
NCT00116805
Start Date
June 1 2005
End Date
January 1 2016
Last Update
March 9 2017
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Orange, California, United States, 92868
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