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

NCT01533051 | Unknown DMC

• 1 other identifier: Quit Anti-viral therapy
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Hepatitis B

Keywords

Chronic hepatitis B; Nucleos(t)ide analogue; Antiviral treatment; Korea

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Chronic hepatitis B

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chronic Hepatitis B patients under anti-viral therapy

You may qualify if:

• More than 20 years old
• Chronic hepatitis B patients under anti-viral therapy
• In HBeAg-positive patient; if HBeAg seroconversion with undetectable HBV DNA is documented on two separate occasions at least 6 months
• In HBeAg-negative patient; if undetectable HBV DNA has been documented on three separate occasions 6 months apart

You may not qualify if:

• Patients who had chronic liver disease due to hemochromatosis, autoimmune hepatitis, drug-induced hepatitis, or thalassemia
• Patients who suffered from other chronic medical condition

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Sang Hoon Ahn

Seoul, 120-752, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Initially, 30ml of heparinized peripheral blood will be obtained from each subjects. After then, 10ml of heparinized peripheral blood will be additionaly obtained at every 3 months follow-up visit.

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sang Hoon Ahn, MD, PhD

  Department of Internal Medicine, Yonsei Universtiy College of Medicine

  STUDY CHAIR

Central Study Contacts

Hana Park, MD

CONTACT

02-2228-1931; PHN223@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 7, 2012
• First Posted: February 15, 2012
• Study Start: February 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2016
• Last Updated: May 8, 2012

Record last verified: 2012-05

Locations

KR (1)