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

NCT02017587 | Unknown

• 1 other identifier: HBV-001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• T lymphocyte phenotype and functional response in chronic HBV infection

  Phenotype CD4+ and CD8+ subsets - activation markers and negative regulators - CD4+ functional response. Expression of programmed death 1 (PD-1) and its ligand (PD-L1/B7-H1) on viral antigen-specific T-cells

  Baseline

Study Arms (1)

Chronic HBV

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

Eligibility Criteria

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

Study Population

Patients volunteers

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vaccine and Gene Therapy Institute, Florida: lead

Study Sites (1)

Virginia Commonwealth University Health System

Richmond, Virginia, 23298, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

plasma/serum PBMC

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

• Richard Sterling, MD

  Virginia Commonwealth University Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick D Yeramian, MD

CONTACT

772 345 5669; pyeramian@vgtifl.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: December 20, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 26, 2015

Record last verified: 2015-02

Locations

US (1)