Prospective Exploratory Study to Describe Hepatitis B Virus (HBV) Kinetics During Treatment With Telbivudine
- Registration Number
- NCT00640588
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will explore HBV kinetics in CHB patients during the first 24 weeks of treatment with telbivudine
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Male or female, at least 18 years of age.
- Documented compensated HBeAg negative CHB defined by baseline HBV serology, DNA and ALT criteria.
Exclusion Criteria
- Co-infection with HCV, HDV, or HIV.
- Prior therapy with nucleos(t)ides in NAÏVE patient and prior treatment with lamivudine in patients with suboptimal response to adefovir.
- History of hepatic decompensation
- History of malignancy
- Patient has one or more additional known primary or secondary causes of liver disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Telbivudine Telbivudine 2 oral adefovir Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks
- Primary Outcome Measures
Name Time Method HBV viral load will be measured by HBV DNA quantification in plasma (log opies/mL) at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks
- Secondary Outcome Measures
Name Time Method Liver function assessed at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks HBV genotype measured at baseline at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks
Trial Locations
- Locations (1)
Novartis Investigative Site
🇪🇸Barcelona, Spain