Prospective Observational Cohort Study for the Durability of Anti-viral Therapy in Patients With Chronic Hepatitis B

Chronic Hepatitis B Clinical Trial

Official title:

Phase IV Study of Durability of Anti-viral Therapy in Patients With Chronic Hepatitis B

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01533051
• Other study ID #: Quit Anti-viral therapy
• Status: Recruiting
• Phase: N/A
• First received: February 7, 2012
• Last updated: May 7, 2012
• Start date: February 2012
• Est. completion date: March 2016

Study information

• Verified date: May 2012
• Source: Yonsei University
• Contact: Hana Park, MD
• Phone: 02-2228-1931
• Email: PHN223[@]yuhs.ac
• Is FDA regulated: No
• Health authority: Korea: Institutional Review BoardKorea: Ministry for Health and Welfare
• Study type: Observational

Clinical Trial Summary

The aim of this study is to investigate the off-treatment sustained virological and biochemical response in chronic hepatitis B patients following the guideline by the Asian Pacific Association for the Study of the Liver (APASL) in Korea.

Description:

In the recommendation by the Asian PAcific Association for the Study of the Liver(APASL), antiviral drug is recommended to stop when HBeAg seroconversion has developed for more than 6 months among HBeAg-positive patietns. For HBeAg-negative patients, the APASL consensus recommended stopping anti-viral treatment when HBV DNA remained undetectable for three separates occasion 6 months apart. Nontheless, approximately 25% to 50% of the patients still develop hepatitis relapse after stopping anti-viral therapy even if these recommendations are followed. In this study, the investigators aimed to investigated the off-treatment sustained response in chronic hepatitis B parients following the stopping anti-viral treatment guideline in Korea.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• More than 20 years old

• Chronic hepatitis B patients under anti-viral therapy

1. In HBeAg-positive patient; if HBeAg seroconversion with undetectable HBV DNA is documented on two separate occasions at least 6 months

2. In HBeAg-negative patient; if undetectable HBV DNA has been documented on three separate occasions 6 months apart

Exclusion Criteria:

• Patients who had chronic liver disease due to hemochromatosis, autoimmune hepatitis, drug-induced hepatitis, or thalassemia

• Patients who suffered from other chronic medical condition

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Korea, Republic of	Sang Hoon Ahn	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virological response after stopping anti-viral treatment	The proportion of patients with sustained virological response after stopping anti-viral treatment	Up to 3 years	No