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

April 20, 2020 updated by: Georg Dultz, Johann Wolfgang Goethe University Hospital

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Charité Berlin-Campus Virchow-Klinikum
      • Frankfurt, Germany, 60590
        • Klinikum der J. W. Goethe-Universität
      • Hamburg, Germany
        • Institut für Interdisziplinäre Medizin
      • Hannover, Germany
        • Medizinische Hochschule Hannover
      • Herne, Germany
        • Gastroenterologische Gemeinschaftspraxis Herne
      • Kiel, Germany
        • Gastroenterologische Gemeinschaftspraxis Kiel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with chronic hepatitis B not receiving antiviral therapy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Indication for Antiviral Treatment
Time Frame: 10 years
10 years
Development of hepatocellular carcinoma (HCC)
Time Frame: 10 years
10 years
Progression of Liver Fibrosis
Time Frame: 10 years
10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
HBV-DNA
Time Frame: 10 years
10 years
Quantitative HBsAg
Time Frame: 10 years
10 years
Serum ALT
Time Frame: 10 years
10 years
Serum AFP
Time Frame: 10 years
10 years
FibroTest/ActiTest
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

March 19, 2010

First Submitted That Met QC Criteria

March 19, 2010

First Posted (Estimate)

March 22, 2010

Study Record Updates

Last Update Posted (Actual)

April 22, 2020

Last Update Submitted That Met QC Criteria

April 20, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JWGUHMED1-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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