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

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ClinicalTrials.gov Identifier: NCT01090531
Recruitment Status : Recruiting
First Posted : March 22, 2010
Last Update Posted : May 22, 2012
Information provided by (Responsible Party):

March 19, 2010
March 22, 2010
May 22, 2012
August 2009
August 2019   (Final data collection date for primary outcome measure)
  • Indication for Antiviral Treatment [ Time Frame: 10 years ]
  • Development of hepatocellular carcinoma (HCC) [ Time Frame: 10 years ]
  • Progression of Liver Fibrosis [ Time Frame: 10 years ]
Same as current
Complete list of historical versions of study NCT01090531 on ClinicalTrials.gov Archive Site
  • HBV-DNA [ Time Frame: 10 years ]
  • Quantitative HBsAg [ Time Frame: 10 years ]
  • Serum ALT [ Time Frame: 10 years ]
  • Serum AFP [ Time Frame: 10 years ]
  • FibroTest/ActiTest [ Time Frame: 10 years ]
HBV-DNA, quantitative HBsAg, serum ALT, serum AFP, FibroTest/ActiTest [ Time Frame: 10 years ]
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Patients With Chronic Hepatitis B and Low Viremia Not Receiving Antiviral Therapy
A Multicenter, Prospective, Observational, Long-Term Follow-Up Study of Subjects With Chronic Hepatitis B and Low Viremia Who Do Not Receive Antiviral Therapy
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.
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Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
whole blood, serum
Probability Sample
Patients with chronic hepatitis B not receiving antiviral therapy
Hepatitis B, Chronic
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Not Provided
August 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 79 Years   (Adult, Senior)
Contact: Christoph Sarrazin, MD +496301 ext 5122 sarrazin@em.uni-frankfurt.de
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Johannes Vermehren, Johann Wolfgang Goethe University Hospitals
Johann Wolfgang Goethe University Hospital
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Principal Investigator: Christoph Sarrazin, MD Medizinische Klinik 1, Klinikum der J. W. Goethe-Universität Frankfurt am Main, Germany
Johann Wolfgang Goethe University Hospital
May 2012