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

This study is currently recruiting participants. (see Contacts and Locations)
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

March 19, 2010
May 21, 2012
August 2009
August 2019   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01090531 on ClinicalTrials.gov Archive Site
  • 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 ]
HBV-DNA, quantitative HBsAg, serum ALT, serum AFP, FibroTest/ActiTest [ Time Frame: 10 years ] [ Designated as safety issue: No ]
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
Both
18 Years to 79 Years
No
Contact: Christoph Sarrazin, MD +496301 ext 5122 sarrazin@em.uni-frankfurt.de
Germany
 
NCT01090531
JWGUHMED1-002
No
Johannes Vermehren, Johann Wolfgang Goethe University Hospitals
Johann Wolfgang Goethe University Hospitals
Not Provided
Principal Investigator: Christoph Sarrazin, MD Medizinische Klinik 1, Klinikum der J. W. Goethe-Universität Frankfurt am Main, Germany
Johann Wolfgang Goethe University Hospitals
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP