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

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ClinicalTrials.gov Identifier: NCT02267473
Recruitment Status : Recruiting
First Posted : October 17, 2014
Last Update Posted : October 17, 2014
Information provided by (Responsible Party):
Johannes Vermehren, Johann Wolfgang Goethe University Hospitals

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.

Condition or disease
Hepatitis B, Chronic

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 Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : October 2014
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Change in Kidney Function [ Time Frame: 5 Years ]
    Reproducible change in creatinine >0.3mg/dl or signs of proximal tubular dysfunction

Secondary Outcome Measures :
  1. Kidney relevant Comorbidities [ Time Frame: 5 Years ]
    Proportion of patients with kidney relevant comorbidities like arterial hypertension, diabetes mellitus, gout

  2. Kidney relevant Comedication [ Time Frame: 5 Years ]
    Relevance of Comedication e.g. Non Steroidal AntiInflammatory Drugs (NSAIDs) to the kidney function under oral antiviral treatment of chronic Hepatitis B

  3. HBV-DNS [ Time Frame: 5 Years ]
  4. quantitative HBs Antigen [ Time Frame: 5 Years ]
  5. Mitochondrial Toxicity [ Time Frame: 5 Years ]
    Signs of mitochondrial toxicity under oral antiviral Hepatitis B Treatment like Lipodystrophy or changed fat metabolism

Biospecimen Retention:   Samples Without DNA
spontaneous urine sample to test for proximal tubular function

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with chronic Hepatitis B under oral antiviral treatment with an approved Nucleos(t)ice for a minimal duration of 6 months at study inclusion

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02267473

Universitätsmedizin Mainz Not yet recruiting
Mainz, Rheinland-Pfalz, Germany, 55131
Contact: Martin Sprinzl, MD    +49613117 ext 0    martin.sprinzl@unimedizin-mainz.de   
Klinikum der J. W. Goethe-Universität Recruiting
Frankfurt, Germany, 60590
Contact: Christoph Sarrazin, MD    +496301 ext 5122    sarrazin@em.uni-frankfurt.de   
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital

Responsible Party: Johannes Vermehren, MD, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT02267473     History of Changes
Other Study ID Numbers: JWGUHMED1-008
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: October 17, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic