A Phase 2, Randomized, Double-Blind Study Exploring the Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus Emtricitabine plus Tenofovir DF Fixed-Dose Combination Therapy in Subjects Currently Being Treated with Adefovir Dipivoxil for Chronic Hepatitis B and having Persistent Viral Replication.
- Conditions
- Chronic Hepatitis BMedDRA version: 8.1Level: LLTClassification code 10008910Term: Chronic hepatitis B
- Registration Number
- EUCTR2005-003136-22-DE
- Lead Sponsor
- Gilead Sciences Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
• 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 = 24 weeks but = 96 weeks)
- HBeAg positive or negative at screening
- Plasma HBV DNA = 1000 copies/mL at screening (irrespective of HBeAg status)
- Serum ALT < 10 x ULN
- Creatinine clearance = 70 mL/min
- Hemoglobin = 8 g/dL
- Neutrophils = 1,000 /mm3
• Nucleoside-naïve or lamivudine-experienced (= 12 weeks of therapy)
• Negative serum ß-HCG
• Compliant with adefovir dipivoxil
• Willing and able to provide written informed consent (Note: individuals who have been committed to an institution by virtue of an order issued either by the courts or by a public authority will not be enrolled in this study).
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
• 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 > 1.5 x ULN, prothrombin time (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).
• Prior use of tenofovir DF or entecavir
• Received treatment with interferon or pegylated interferon within 6 months of the screening visit.
• Evidence of HCC; for example, a fetoprotein > 50 ng/mL or by any other standard of care measure.
• Co-infection with HCV (based on serology), HIV, or HDV.
• Significant renal, cardiovascular, pulmonary, or neurological disease.
• Received solid organ or bone marrow transplantation.
• Is currently receiving therapy with immunomodulators (e.g., corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion.
• Has proximal tubulopathy
• Known hypersensitivity to tenofovir DF or emtricitabine/tenofovir DF, tenofovir or emtricitabine or their phosphorylated forms, or study drug product formulation excipients.
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