Apoptosis and Hepatitis B: The Role of Apoptosis in Patients Who Are HBeAg Negative

NCT00152880 | Unknown

• 1 other identifier: 05-0337-T
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A large number hepatitis B surface antigen positive individuals are HBeAg negative with normal liver tests. Historically, such patients were thought to have suppressed viral replication and were considered to be at low risk for complications. With the use of more sensitive technology, physicians are now able to identify a group of patients who are HBeAg negative, have normal liver enzymes, and detectable HBV DNA. Some of these patients develop signs of liver inflammation and fibrosis on biopsy. We intend to investigate whether normal, programmed cell death (apoptosis) plays a role in causing the silent liver injury in this group of patients. In other words the purpose of this study is to see whether apoptosis may be responsible for the silent liver death and injury that occurs in these so called inactive carriers who are HBeAg negative, have normal serum ALT values and HBV DNA \> 10,000 copies/mL. In this study the liver biopsies would be routinely collected in the clinic and investigated for the evidence of inflammation and fibrosis, and special testing would be performed to detect for evidence of apoptosis. Around 30 patients from UHN would be participating in this study. This study will test the hypothesis that subjects who are HBeAg negative, have normal ALT and have HBV DNA ≥10,000 copies/mL will demonstrate an increased rate of apoptosis in liver tissue compared to healthy age-matched controls. If this hypothesis is confirmed, it will imply that the previous assumption that this group of patients has inactive disease is false and would implicate apoptosis as an important mechanism responsible for causing liver damage. If apoptotic activity is indeed elevated, further study of these pathways could potentially yield therapeutic interventions to inhibit apoptosis.

Conditions

Hepatitis B

Keywords

Hepatitis B, apoptosis

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HBsAg positive.
• Stable HBeAg status for at least one year prior to biopsy.
• Normal ALT levels (defined as \<1.5 x the upper limit of normal) for at least 90 days prior to biopsy.
• HBV DNA ≥10,000 copies/mL by PCR measured within 90 days of liver biopsy.
• patients attending Liver Clinic at Toronto Western Hospital, Toronto, ON, Canada

You may not qualify if:

• Coinfection with viral hepatitis A, C or D.
• Coinfection with HIV.
• Presence of Hepatoma.
• Known presence of other malignancy.
• Previous antiviral treatment.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Liver Clinic, Toronto Western Hospital, UHN.

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• E.J.L (Jenny) Heathcote, MD

  UHN - Toronto Western Hospital, University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brandusa Florica

CONTACT

416-603-6232

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: OTHER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 9, 2005
• Study Start: July 1, 2005
• Last Updated: December 1, 2005

Record last verified: 2005-09

Locations

CA (1)