Hepatitis B, Chronic
Conditions
Brief summary
Patients with chronic Hepatitis B who are under oral antiviral treatment for at least 6 months at study start will be monitored once yearly for kidney function changes within their routine outpatient visit. Therefore urine samples will be collected and some additional blood test will be done within the routine blood sampling.
Detailed description
This non-interventional, long-term observational cohort study will evaluate demographic, clinical, biochemical and virological parameters of outpatients with chronic Hepatitis B who are under oral antiviral treatment with an approved Nucleos(t)ide for \> 6 months at study inclusion. During their routine outpatient visits annually an assessment of their kidney function especially for a proximal tubular dysfunction will be performed and their comedication will be explored. Patients included in the study are followed up for 5 years.
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 89 Years
Healthy volunteers
No
Inclusion criteria
* chronic Hepatitis B Virus infection * indication for an antiviral treatment due to the recent german Hepatitis B guidelines and oral intake of an approved Nucleos(t)ide for a minimum of 6 months at inclusion * ALT \< 2 x UNL (upper normal limit) at study inclusion * age 18 - 89 years * signed informed consent form
Exclusion criteria
* coinfection with Hepatitis D Virus (HDV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) * Comorbidities that will hinder the study performance (e.g. malignancies, relevant psychiatric disorder) * hepatocellular carcinoma or hepatic metastases * legally incapacitated patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Kidney Function | 5 Years | Reproducible change in creatinine \>0.3mg/dl or signs of proximal tubular dysfunction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kidney relevant Comorbidities | 5 Years | Proportion of patients with kidney relevant comorbidities like arterial hypertension, diabetes mellitus, gout |
| Kidney relevant Comedication | 5 Years | Relevance of Comedication e.g. Non Steroidal AntiInflammatory Drugs (NSAIDs) to the kidney function under oral antiviral treatment of chronic Hepatitis B |
| HBV-DNS | 5 Years | — |
| quantitative HBs Antigen | 5 Years | — |
| Mitochondrial Toxicity | 5 Years | Signs of mitochondrial toxicity under oral antiviral Hepatitis B Treatment like Lipodystrophy or changed fat metabolism |
Countries
Germany
Outcome results
None listed