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Patients With Chronic Hepatitis B and Low Viremia Not Receiving Antiviral Therapy

This study is currently recruiting participants.
Verified May 2012 by Johann Wolfgang Goethe University Hospitals
Sponsor:
Information provided by (Responsible Party):
Johannes Vermehren, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01090531
First received: March 19, 2010
Last updated: May 21, 2012
Last verified: May 2012
History of Changes
  Purpose

This observational long-term follow-up study will evaluate demographic, clinical, histological, biochemical, and virological parameters of patients with chronic hepatitis B and low viremia who do not require antiviral therapy according to current guidelines. Liver stiffness values as detected by FibroScan and ARFI will also be collected if available. All data will be collected at yearly intervals (minimum). Patients included in the study are followed for up to 10 years. The target sample size is <1000.


Condition
Hepatitis B, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter, Prospective, Observational, Long-Term Follow-Up Study of Subjects With Chronic Hepatitis B and Low Viremia Who Do Not Receive Antiviral Therapy

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Indication for Antiviral Treatment [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Development of hepatocellular carcinoma (HCC) [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Progression of Liver Fibrosis [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HBV-DNA [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Quantitative HBsAg [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Serum ALT [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Serum AFP [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • FibroTest/ActiTest [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood, serum


Estimated Enrollment: 600
Study Start Date: August 2009
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with chronic hepatitis B not receiving antiviral therapy

Criteria

Inclusion Criteria:

  • adult patient, age 18-79
  • chronic hepatitis B
  • HBV-DNA < 100.000 IU/ml
  • ALT ≤2 x ULN
  • recent liver histology and/or FibroScan measurement
  • willingness to sign informed consent

Exclusion Criteria:

  • current or past antiviral therapy for hepatitis B
  • chronic hepatitis B in immune tolerance phase (HBeAg positive, high viral load)
  • co-infection with HIV, HCV
  • malignant disease
  • HCC or other liver tumor
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01090531

Contacts
Contact: Christoph Sarrazin, MD +496301 ext 5122 sarrazin@em.uni-frankfurt.de

Locations
Germany
Charité Berlin-Campus Virchow-Klinikum Recruiting
Berlin, Germany
Klinikum der J. W. Goethe-Universität Recruiting
Frankfurt, Germany, 60590
Contact: Christoph Sarrazin, MD     +496301 ext 5122     sarrazin@em.uni-frankfurt.de    
Institut für Interdisziplinäre Medizin Recruiting
Hamburg, Germany
Medizinische Hochschule Hannover Recruiting
Hannover, Germany
Gastroenterologische Gemeinschaftspraxis Herne Recruiting
Herne, Germany
Gastroenterologische Gemeinschaftspraxis Kiel Recruiting
Kiel, Germany
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
Principal Investigator: Christoph Sarrazin, MD Medizinische Klinik 1, Klinikum der J. W. Goethe-Universität Frankfurt am Main, Germany
  More Information

No publications provided

Responsible Party: Johannes Vermehren, MD, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01090531     History of Changes
Other Study ID Numbers: JWGUHMED1-002
Study First Received: March 19, 2010
Last Updated: May 21, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices, Bonn

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Hepatitis, Viral, Human
Viremia
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013