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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 Johannes Vermehren, Johann Wolfgang Goethe University Hospitals
Sponsor:
ClinicalTrials.gov Identifier:
NCT01090531
First Posted: March 22, 2010
Last Update Posted: May 22, 2012
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
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 ]
Not Provided
Not Provided
 
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
whole blood, serum
Probability Sample
Patients with chronic hepatitis B not receiving antiviral therapy
Hepatitis B, Chronic
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
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)
No
Contact: Christoph Sarrazin, MD +496301 ext 5122 sarrazin@em.uni-frankfurt.de
Germany
 
 
NCT01090531
JWGUHMED1-002
No
Not Provided
Not Provided
Johannes Vermehren, Johann Wolfgang Goethe University Hospitals
Johann Wolfgang Goethe University Hospital
Not Provided
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