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

Status unconfirmed

Conditions studied: Chronic Hepatitis B

In brief

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.

Key facts

Study ID

NCT02017587

Run by

Vaccine and Gene Therapy Institute, Florida

People needed

40

Starts

2013-12-01

Expected to finish

2015-12-01

Last updated by the study team

2015-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Virginia Commonwealth University Health System — Richmond, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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