Chronic hepatitis B
Conditions
Brief summary
HBsAg negativity at week 12 of antiviral therapy
Detailed description
HBsAg decline at weeks 1, 2, 4, 8 and 12 of treatment, post-treatment HBsAg negativity up to FU week 24, HBV DNA levels during and after hepatitis B immunoglobulin treatment will be reported for each cohort, biochemical response (proportion of subjects who reached ALT normalization (ALT ≤ ULN) at week 12 of treatment), quality of life during treatment and follow-up (SF-36)
Interventions
DRUGHepatect CP 50 I.E./ml Infusionslösung
DRUGZutectra 500 IU solution for injection in pre-filled syringe
Sponsors
Medizinische Hochschule Hannover, Medizinische Hochschule Hannover
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg negativity at week 12 of antiviral therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| HBsAg decline at weeks 1, 2, 4, 8 and 12 of treatment, post-treatment HBsAg negativity up to FU week 24, HBV DNA levels during and after hepatitis B immunoglobulin treatment will be reported for each cohort, biochemical response (proportion of subjects who reached ALT normalization (ALT ≤ ULN) at week 12 of treatment), quality of life during treatment and follow-up (SF-36) | — |
Countries
Germany
Outcome results
None listed