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

• Conditions: Hepatitis B, Chronic

• Registration Number: NCT01090531
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-03-19
• Study First Submitted QC: 2010-03-19
• Study First Posted: 2010-03-22
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-20
• Last Update Posted: 2020-04-22
• Primary Completion: 2021-08
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression of Liver Fibrosis	10 years
Indication for Antiviral Treatment	10 years
Development of hepatocellular carcinoma (HCC)	10 years

Secondary Outcome Measures

Name	Time	Method
Serum AFP	10 years
FibroTest/ActiTest	10 years
Serum ALT	10 years
Quantitative HBsAg	10 years
HBV-DNA	10 years

Trial Locations

Locations (6)

Gastroenterologische Gemeinschaftspraxis Herne; 🇩🇪 Herne, Germany

Institut für Interdisziplinäre Medizin; 🇩🇪 Hamburg, Germany

Gastroenterologische Gemeinschaftspraxis Kiel; 🇩🇪 Kiel, Germany

Klinikum der J. W. Goethe-Universität; 🇩🇪 Frankfurt, Germany

Charité Berlin-Campus Virchow-Klinikum; 🇩🇪 Berlin, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany