Recruiting

Observational Study

Sponsor:

Vaccine and Gene Therapy Institute, Florida

Code:

NCT02017587

Conditions

Chronic Hepatitis B

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT02017587

Start date

Dec, 2013

Status verified date

Feb, 2015

Completion date

Dec, 2015

Anticipated

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Chronic HBV

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

Primary outcome measure

  • T lymphocyte phenotype and functional response in chronic HBV infection [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Patrick D Yeramian, MD

772 345 5669pyeramian@vgtifl.org

Locations

Virginia Commonwealth University Health System

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Paula G Smith, RN

pgsmith@vcu.edu

Principal Investigator:

Richard sterling, MD

More Information

Sponsor

Vaccine and Gene Therapy Institute, Florida

Last update posted

Feb 26, 2015

Last verified

Feb, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vaccine and Gene Therapy Institute, Florida on 2015-02-26.