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

• Conditions: Hepatitis B, Chronic

• Registration Number: NCT02267473
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-14
• Study First Submitted QC: 2014-10-14
• Study First Posted: 2014-10-17
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-30
• Last Update Posted: 2018-04-02
• Primary Completion: 2020-10
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Kidney Function	5 Years	Reproducible change in creatinine \>0.3mg/dl or signs of proximal tubular dysfunction

Secondary Outcome Measures

Name	Time	Method
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
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
Kidney relevant Comorbidities	5 Years	Proportion of patients with kidney relevant comorbidities like arterial hypertension, diabetes mellitus, gout

Trial Locations

Locations (2)

Klinikum der J. W. Goethe-Universität; 🇩🇪 Frankfurt, Germany

Universitätsmedizin Mainz; 🇩🇪 Mainz, Rheinland-Pfalz, Germany