hepatitis B liver inflammation
Conditions
Interventions
There are three treatment groups:
1)Telbivudine monotherapy: 104 weeks of oral therapy
2)Combination therapy: 52 weeks of peginterferon alpha-2a and 104 weeks of
telbivudine
3)Peginterferon alpha-2a
Sponsors
Novartis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, at least 18 years of age. 2. Documented Cronic Hepatitis B (CHB) defined by all of the following: *Clinical history compatible with CHB *Detectable serum HBsAg at the Screening visit and at least 6 months prior *HBeAg-positive at the Screening visit *HBeAb-negative at the Screening visit *Documented history of evidence of chronic liver inflammation, *Elevated serum ALT level (1.3 * 10 x upper limit of normal (ULN)) at screening *Serum HBV DNA level * 6 log10 copies/mL (central lab), at screening *Documented chronic liver inflammation on previous liver biopsy within the previous 24 months
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures or their excipients. 2. Co-infection with hepatitis C virus (HCV), hepatitis D virus (HDV), or Human immunodeficiency virus (HIV). 3. Current or passed use of excluded drug therapy e.g. other investigational therapy, immunomodulatory treatment, nucleoside or nucleoitide therapy 4. Medical condition requiring prolonged use of corticosteroids, hepatotoxic drugs or nephrotoxic drugs. 5. Alcohol or illicit drug abuse within the preceding 2 years 6. Patient is on thyroid therapy and dose is not stable for at least 5 weeks prior to Visit 2/Baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy variable of this study is the proportion of patients who will achieve HBV DNA non-detectability by PCR at Week 52. The proportion of patients (response rate) who will achieve HBV DNA non-detectability at Week 52 and ALT normalization after 52 weeks* treatment will be tested using the CMH test, stratified by country and/or baseline HBV DNA level. The ratio of the response rates and the difference of the response rates for combination therapy vs. peginterferon alfa-2a monotherapy will be provided along with a 95% confidence interval. | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients (response rate) who will achieve HBV DNA non-detectability at Week 52 and ALT normalization after 52 weeks* treatment will be tested using the CMH test. | — |
Countries
Netherlands
Outcome results
None listed