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.
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.
Study Type
OBSERVATIONAL
Enrollment
300
Universitätsmedizin Mainz
Mainz, Rhineland-Palatinate, Germany
Klinikum der J. W. Goethe-Universität
Frankfurt, Germany
Change in Kidney Function
Reproducible change in creatinine \>0.3mg/dl or signs of proximal tubular dysfunction
Time frame: 5 Years
Kidney relevant Comorbidities
Proportion of patients with kidney relevant comorbidities like arterial hypertension, diabetes mellitus, gout
Time frame: 5 Years
Kidney relevant Comedication
Relevance of Comedication e.g. Non Steroidal AntiInflammatory Drugs (NSAIDs) to the kidney function under oral antiviral treatment of chronic Hepatitis B
Time frame: 5 Years
HBV-DNS
Time frame: 5 Years
quantitative HBs Antigen
Time frame: 5 Years
Mitochondrial Toxicity
Signs of mitochondrial toxicity under oral antiviral Hepatitis B Treatment like Lipodystrophy or changed fat metabolism
Time frame: 5 Years
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