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Trial record 66 of 360 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Johann Wolfgang Goethe University Hospital
Information provided by (Responsible Party):
Johannes Vermehren, Johann Wolfgang Goethe University Hospitals Identifier:
First received: October 14, 2014
Last updated: NA
Last verified: October 2014
History: No changes posted
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.

Hepatitis B, Chronic

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Johann Wolfgang Goethe University Hospital:

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

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

  • 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

  • HBV-DNS [ Time Frame: 5 Years ]
  • quantitative HBs Antigen [ Time Frame: 5 Years ]
  • 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

Estimated Enrollment: 400
Study Start Date: October 2014
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)
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.


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02267473

Universitätsmedizin Mainz Not yet recruiting
Mainz, Rheinland-Pfalz, Germany, 55131
Contact: Martin Sprinzl, MD    +49613117 ext 0   
Klinikum der J. W. Goethe-Universität Recruiting
Frankfurt, Germany, 60590
Contact: Christoph Sarrazin, MD    +496301 ext 5122   
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
  More Information

Responsible Party: Johannes Vermehren, MD, Johann Wolfgang Goethe University Hospitals Identifier: NCT02267473     History of Changes
Other Study ID Numbers: JWGUHMED1-008
Study First Received: October 14, 2014
Last Updated: October 14, 2014

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections processed this record on April 28, 2017