Hepatitis B, Chronic
Conditions
Brief summary
This observational long-term follow-up study will evaluate demographic, clinical, histological, biochemical, and virological parameters of patients with chronic hepatitis B and low viremia who do not require antiviral therapy according to current guidelines. Liver stiffness values as detected by FibroScan and ARFI will also be collected if available. All data will be collected at yearly intervals (minimum). Patients included in the study are followed for up to 10 years. The target sample size is \<1000.
Interventions
None listed
Sponsors
Johann Wolfgang Goethe University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* adult patient, age 18-79 * chronic hepatitis B * HBV-DNA \< 100.000 IU/ml * ALT ≤2 x ULN * recent liver histology and/or FibroScan measurement * willingness to sign informed consent
Exclusion criteria
* current or past antiviral therapy for hepatitis B * chronic hepatitis B in immune tolerance phase (HBeAg positive, high viral load) * co-infection with HIV, HCV * malignant disease * HCC or other liver tumor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Indication for Antiviral Treatment | 10 years |
| Development of hepatocellular carcinoma (HCC) | 10 years |
| Progression of Liver Fibrosis | 10 years |
Secondary
| Measure | Time frame |
|---|---|
| Serum AFP | 10 years |
| HBV-DNA | 10 years |
| FibroTest/ActiTest | 10 years |
| Quantitative HBsAg | 10 years |
| Serum ALT | 10 years |
Countries
Germany
Outcome results
None listed