A Randomized, Double-Blind, Controlled Evaluation of Tenofovir DF versus Adefovir Dipivoxil for the Treatment of HBeAg Positive Chronic Hepatitis B
- Conditions
- Chronic Hepatitis BMedDRA version: 7.1Level: LLTClassification code 10008910
- Registration Number
- EUCTR2004-005120-41-ES
- Lead Sponsor
- Gilead Sciences Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 271
1) Chronic HBV infection, defined as positive serum HBsAg for more than 6 months.
2) 18 through 69 years of age, inclusive.
3) Active HBeAg positive chronic HBV infection, with all of the following:
• HBeAg positive at screening
• ALT levels > 2 x ULN and = 10 x ULN
• Serum HBV DNA >1000000 copies/mL at screening
• creatinine clearance = 70 mL/min
• hemoglobin = 8 g/dL
• neutrophils = 1,000 /mm3
4) Knodell necroinflammatory score = 3 and a Knodell fibrosis score < 4. However, up to 96 patients with cirrhosis, i.e., a Knodell fibrosis score equal to 4, will be eligible for enrollment.
5) Negative serum ß-HCG
6) Nucleotide naïve, i.e., no prior nucleotide (tenofovir DF or adefovir dipivoxil) therapy for greater than 12 weeks.
7) Nucleoside naïve, i.e., no prior nucleoside (any nucleoside) therapy for greater than 12 weeks.
8) Willing and able to provide written informed consent.
9) Had a liver biopsy performed within 6 months of baseline and has readable biopsy slides or agrees to have a biopsy performed prior to baseline.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1) Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study.
2) 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.
3) Decompensated liver disease defined as conjugated bilirubin >1.5 x ULN, 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).
4) Received any nucleoside, nucleotide (tenofovir DF or adefovir dipivoxil) or interferon (pegylated or not) therapy within 6 months prior of the pre-treatment biopsy.
5) Evidence of hepatocellular carcinoma (HCC), i.e., a fetoprotein > 50 ng/mL.
6) Co-infection with HCV, HIV, or HDV.
7) Significant renal, cardiovascular, pulmonary, or neurological disease.
8) Received solid organ or bone marrow transplantation.
9) Is currently receiving therapy with immunomodulators (e.g., corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion.
10) Has proximal tubulopathy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method