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

Hepatitis B, Chronic Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01090531
• Other study ID #: JWGUHMED1-002
• Status: Active, not recruiting
• Start date: August 2009
• Est. completion date: August 2021

Study information

• Verified date: April 2020
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Viremia

Locations

Country	Name	City	State
Germany	Charité Berlin-Campus Virchow-Klinikum	Berlin
Germany	Klinikum der J. W. Goethe-Universität	Frankfurt
Germany	Institut für Interdisziplinäre Medizin	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Gastroenterologische Gemeinschaftspraxis Herne	Herne
Germany	Gastroenterologische Gemeinschaftspraxis Kiel	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Indication for Antiviral Treatment		10 years
Primary	Development of hepatocellular carcinoma (HCC)		10 years
Primary	Progression of Liver Fibrosis		10 years
Secondary	HBV-DNA		10 years
Secondary	Quantitative HBsAg		10 years
Secondary	Serum ALT		10 years
Secondary	Serum AFP		10 years
Secondary	FibroTest/ActiTest		10 years