Hepatitis B, Chronic
Conditions
Keywords
Viral kinetics, Viral dynamics, Telbivudine, Lamivudine
Brief summary
This study examines the effect of telbivudine compared to lamivudine on the early viral kinetics in patients with chronic hepatitis B. The virus Kinetics is measured by the viral load (HBV-DNA) reduction in the serum during the first 12 weeks of therapy.
Interventions
DRUGLamivudine
100 mg/day
DRUGTelbivudine
600 mg/day
Sponsors
Novartis
University of Ulm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Documented compensated HBeAg-positive or negative chronic hepatitis B * Increased viral load with a concentration of serum HBV-DNA of at least 10\^4 copies/ml * Proof of inflammatory activity in the liver: ALT ≥ 2 x ULN or histological evidence of inflammatory activity ≥ level I or fibrosis of ≥ I degrees (according to the Desmet classification) * Negative urine pregnancy test with fertile women * Willingness to use a recognized method of contraception * Able to comply with study regimen and provide written informed consent
Exclusion criteria
* Current or previous antiviral treatment of chronic hepatitis B with Nucleus(t)id analoga * Known hypersensitivity to lamivudine or telbivudine or any of the other components of the preparations * Pregnant or breastfeeding women or women * Simultaneous participation in other clinical trials or in the past three months * Co-infected with HCV, HDV, HIV * Other non HBV-related chronic liver disease: Autoimmune hepatitis, primary biliary cirrhosis, Hemochromatosis, alpha-1 antitrypsin deficiency, alcoholic hepatitis * Evidence of hepatocellular carcinoma (alpha-fetoprotein levels\> 100 ng/ml) * Active drug use, including an excessive alcohol consumption during the last 6 months before participating in the clinical trial * Use of systemic treatment with anti-neoplastic or immunomodulatory medication within the last 6 months before participating in the clinical trial and during the duration of the clinical examination * Lack of willingness or inability to consent in writing * Concurrent condition likely to preclude compliance with schedule of evaluations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in viral load after 2 weeks of therapy measured in serum HBV-DNA concentration (Copies/ml or IU/ml). | 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Course of the viral load (serum HBV-DNA) during the first 12 weeks of therapy | 12 weeks |
| Influence of HBeAg status to the decrease in viral load | 12 weeks |
| Influence of HBV genotype to the decrease in viral load | 12 weeks |
| Change in ALT and AST levels from Baseline to Week 12 | 12 weeks |
| Development of viral resistance and treatment failure during the study and subsequent course of observation | 6 month |
| Safety assessed by adverse events and laboratory values | 6 month |
Countries
Germany
Outcome results
None listed