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

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. Identifier: NCT01090531
Recruitment Status : Recruiting
First Posted : March 22, 2010
Last Update Posted : May 22, 2012
Information provided by (Responsible Party):
Johannes Vermehren, Johann Wolfgang Goethe University Hospitals

Brief Summary:
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 or disease
Hepatitis B, Chronic

Study Type : Observational
Estimated Enrollment : 600 participants
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
Study Start Date : August 2009
Estimated Primary Completion Date : August 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Indication for Antiviral Treatment [ Time Frame: 10 years ]
  2. Development of hepatocellular carcinoma (HCC) [ Time Frame: 10 years ]
  3. Progression of Liver Fibrosis [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. HBV-DNA [ Time Frame: 10 years ]
  2. Quantitative HBsAg [ Time Frame: 10 years ]
  3. Serum ALT [ Time Frame: 10 years ]
  4. Serum AFP [ Time Frame: 10 years ]
  5. FibroTest/ActiTest [ Time Frame: 10 years ]

Biospecimen Retention:   Samples With DNA
whole blood, serum

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with chronic hepatitis B not receiving antiviral therapy

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

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 identifier (NCT number): NCT01090531

Contact: Christoph Sarrazin, MD +496301 ext 5122

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   
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 Hospital
Principal Investigator: Christoph Sarrazin, MD Medizinische Klinik 1, Klinikum der J. W. Goethe-Universität Frankfurt am Main, Germany

Responsible Party: Johannes Vermehren, MD, Johann Wolfgang Goethe University Hospitals Identifier: NCT01090531     History of Changes
Other Study ID Numbers: JWGUHMED1-002
First Posted: March 22, 2010    Key Record Dates
Last Update Posted: May 22, 2012
Last Verified: May 2012

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