Procurement of Blood Samples for a Biomedical Research Program on T Cell Functional Response to Chronic HBV Infection

NCT ID: NCT02017587

Last Updated: 2015-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-12-31

Brief Summary

The objective of the study is to procure blood (plasma, serum, RNA and PBMC samples) from approximately 40 chronic HBV for biomedical research program led by VGTI Florida.

Detailed Description

During chronic HBV infection, a dynamic balance between viral replication and the host immune response is pivotal to the pathogenesis of liver disease. HBV specific T-cell function is impaired in patients with chronic HBV infection characterized by low levels of antiviral cytokines, impaired cytotoxic T lymphocyte activity, and persistent viremia. However, the mechanism underlying this T-cell malfunction in chronic HBV infection has not been completely understood.

The biomedical research on the samples obtained during this study will include, among other studies, advanced flow cytometry to study the Treg and activation markers, negative regulatory molecules and phenotype of CD4 and CD8 subsets using the extended panel markers developed at VGTI Florida. Additional antibody panels for measuring functional CD4 responses by ICS, DC subsets, activation, and signaling pathways by phos

Conditions

Chronic Hepatitis B

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Chronic HBV

chronic HBV strata: HBV tolerant, Chronic active HBe+ or HBe-, suppressed with antiviral therapy

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patient with chronic HBV infection documented by presence of HBsAg for at least 12 months currently untreated for HBV infection or under stable antiviral therapy

Exclusion Criteria

• Prior use of HBV therapeutic vaccine
• Currently treated with interferon alpha or other immune modulator(s)
• Acute HBV infection
• Chronic inactive HBV carrier
• under an acute flare/reactivation of HBV infection defined as symptoms of acute hepatitis and recent elevation of aminotransferase (over 10 x ULN) or bilirubin levels
• Known co-infection with HCV, HDV, and/or HIV
• Under renal dialysis
• For female patients, pregnant or breastfeeding
• Cirrhosis, hepatocellular carcinoma or liver transplantation
• active autoimmune disease including autoimmune hepatitis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vaccine and Gene Therapy Institute, Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Sterling, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University Health System

Locations

Virginia Commonwealth University Health System

Richmond, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Patrick D Yeramian, MD

Role: CONTACT

pyeramian@vgtifl.org

772 345 5669

Facility Contacts

Paula G Smith, RN

Role: primary

pgsmith@vcu.edu

Other Identifiers

HBV-001

Identifier Type: -

Identifier Source: org_study_id