Hepatitis B Patients Under Oral Nucleos(t)Ide Treatment With Intermittent Assessment of Kidney Function

Study Overview
=================
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.

Official Title
-----------------
A Multicenter, Prospective, Observational Study of Patients With Chronic Hepatitis B Under Various Oral Nucleos(t)Ide Treatment With Intermittent Assessment of Kidney Function

Conditions
-----------------
Hepatitis B, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Kidney Function | Reproducible change in creatinine >0.3mg/dl or signs of proximal tubular dysfunction | 5 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney relevant Comorbidities | Proportion of patients with kidney relevant comorbidities like arterial hypertension, diabetes mellitus, gout | 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 | 5 Years | 
| HBV-DNS |  | 5 Years | 
| quantitative HBs Antigen |  | 5 Years | 
| Mitochondrial Toxicity | Signs of mitochondrial toxicity under oral antiviral Hepatitis B Treatment like Lipodystrophy or changed fat metabolism | 5 Years |