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

NCT ID: NCT01090531

Last Updated: 2020-04-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2021-08-31

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.

Conditions

Hepatitis B, Chronic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Georg Dultz

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christoph Sarrazin, MD

Role: PRINCIPAL_INVESTIGATOR

Medizinische Klinik 1, Klinikum der J. W. Goethe-Universität Frankfurt am Main, Germany

Locations

Charité Berlin-Campus Virchow-Klinikum

Berlin, , Germany

Klinikum der J. W. Goethe-Universität

Frankfurt, , Germany

Institut für Interdisziplinäre Medizin

Hamburg, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Gastroenterologische Gemeinschaftspraxis Herne

Herne, , Germany

Gastroenterologische Gemeinschaftspraxis Kiel

Kiel, , Germany

Countries

Germany

Other Identifiers

JWGUHMED1-002

Identifier Type: -

Identifier Source: org_study_id