A Randomized, Double-Blind, Controlled Evaluation of Tenofovir DF versus Adefovir Dipivoxil for the Treatment of HBeAg Positive Chronic Hepatitis B.
- Conditions
- Treatment of HBeAg positive chronic hepatitis BMedDRA version: 15.1Level: LLTClassification code 10019743Term: Hepatitis B virus (HBV)System Organ Class: 100000004848Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2004-005120-41-IT
- Lead Sponsor
- Gilead Sciences Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
- Adult patients (18-69 years of age) with HBeAg positive chronic hepatitis B (HBsAg positive for more than 6 months), with serum HBV DNA > 10 6 copies/mL, ALT levels > 2 x ULN and ≤ 10 x ULN and a Knodell necroinflammatory score of ≥ 3 and a Knodell fibrosis score < 4. - Patients who have not had a biopsy within 6 months of screening must agree to undergo a liver biopsy prior to randomization. - No evidence of hepatocellular carcinoma (HCC). - Patients are eligible if they are treatment naïve, i.e., less than 12 weeks of prior nucleoside or nucleotide (adefovir dipivoxil or tenofovir DF) treatment. - Any previous treatment with nucleosides and nucleotides and interferon must have ended at least 6 months prior to the pre-treatment biopsy. - Patients must be without HIV, HCV and HDV infection. Pregnant and breast-feeding women will be excluded from the study and patients with decompensated liver disease or a history of decompensated liver disease will be excluded from the study.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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
? Pregnant women, women who are breast feeding ? Males and females of reproductive potential who are unwilling to use an 'effective' method of contraception during the study. ? Decompensated liver disease or prior history of clinical hepatic decompensation. ? Received any nucleoside, nucleotide (tenofovir DF or adefovir dipivoxil) or interferon therapy within 6 months prior of the pre-treatment biopsy. ? Evidence of hepatocellular carcinoma (HCC) ? Co infection with HCV, HIV, or HDV. ? Significant renal, cardiovascular, pulmonary, or neurological disease. ? Received solid organ or bone marrow transplantation. ? Is currently receiving therapy with immunomodulators, nephrotoxic agents. ? 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