Status:
UNKNOWN
Hepatitis B Patients Under Oral Nucleos(t)Ide Treatment With Intermittent Assessment of Kidney Function
Lead Sponsor:
Johann Wolfgang Goethe University Hospital
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-89 years
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 ...
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 ant...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT02267473
Start Date
October 1 2014
End Date
December 1 2020
Last Update
April 2 2018
Active Locations (2)
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1
Universitätsmedizin Mainz
Mainz, Rhineland-Palatinate, Germany, 55131
2
Klinikum der J. W. Goethe-Universität
Frankfurt, Germany, 60590