We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified October 2014 by Johannes Vermehren, Johann Wolfgang Goethe University Hospitals
Sponsor:
ClinicalTrials.gov Identifier:
NCT02267473
First Posted: October 17, 2014
Last Update Posted: October 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Johannes Vermehren, Johann Wolfgang Goethe University Hospitals
  Purpose
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
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 Johannes Vermehren, Johann Wolfgang Goethe University Hospitals:

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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Criteria

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
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


Locations
Germany
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
  More Information

Responsible Party: Johannes Vermehren, MD, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT02267473     History of Changes
Other Study ID Numbers: JWGUHMED1-008
First Submitted: October 14, 2014
First Posted: October 17, 2014
Last Update Posted: October 17, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Hepatitis
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