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

Sponsor

Johann Wolfgang Goethe University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01090531

Collaborator

(none)

1,000

Enrollment

Locations

144

Duration (Months)

166.7

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B, Chronic

Study Design

Study Type:

Observational

Actual Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Multicenter, Prospective, Observational, Long-Term Follow-Up Study of Subjects With Chronic Hepatitis B and Low Viremia Who Do Not Receive Antiviral Therapy

Study Start Date :

Aug 1, 2009

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Outcome Measures

Primary Outcome Measures

Indication for Antiviral Treatment [10 years]
Development of hepatocellular carcinoma (HCC) [10 years]
Progression of Liver Fibrosis [10 years]

Secondary Outcome Measures

HBV-DNA [10 years]
Quantitative HBsAg [10 years]
Serum ALT [10 years]
Serum AFP [10 years]
FibroTest/ActiTest [10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Charité Berlin-Campus Virchow-Klinikum	Berlin	Germany
2	Klinikum der J. W. Goethe-Universität	Frankfurt	Germany	60590
3	Institut für Interdisziplinäre Medizin	Hamburg	Germany
4	Medizinische Hochschule Hannover	Hannover	Germany
5	Gastroenterologische Gemeinschaftspraxis Herne	Herne	Germany
6	Gastroenterologische Gemeinschaftspraxis Kiel	Kiel	Germany