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

Johann Wolfgang Goethe University Hospital

Status: Unknown

Conditions: Hepatitis B, Chronic

Study type: Observational

Funder types: Other

Identifiers

NCT01090531

JWGUHMED1-002

Details and patient eligibility

About

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.

Enrollment: 1,000 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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