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

Hepatitis B, Chronic Clinical Trial

— BONIKA  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02267473
• Other study ID #: JWGUHMED1-008
• Status: Active, not recruiting
• First received: October 14, 2014
• Last updated: March 30, 2018
• Start date: October 2014
• Est. completion date: December 2020

Study information

• Verified date: March 2018
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Locations

Country	Name	City	State
Germany	Klinikum der J. W. Goethe-Universität	Frankfurt
Germany	Universitätsmedizin Mainz	Mainz	Rheinland-Pfalz

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Kidney Function	Reproducible change in creatinine >0.3mg/dl or signs of proximal tubular dysfunction	5 Years
Secondary	Kidney relevant Comorbidities	Proportion of patients with kidney relevant comorbidities like arterial hypertension, diabetes mellitus, gout	5 Years
Secondary	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
Secondary	HBV-DNS		5 Years
Secondary	quantitative HBs Antigen		5 Years
Secondary	Mitochondrial Toxicity	Signs of mitochondrial toxicity under oral antiviral Hepatitis B Treatment like Lipodystrophy or changed fat metabolism	5 Years