HBRN: Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of Chronic Hepatitis B

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

Aim 1. Therapeutic HBV suppression will enhance antiviral immune effector responses and reduce immune inhibitory factors in participants with chronic hepatitis B. This study will also examine if antiviral therapy has a durable effect in host immune phenotype and define the immunological effect of interferon-alpha (IFNα) therapy in chronic HBV participants. Aim 2. Antiviral immune effector and regulatory responses before, during and/or after therapy can predict long term therapeutic response.

Who is eligible to participate?

Inclusion Criteria: - Ability to provide informed consent for participation in the ancillary study Exclusion Criteria: - Children under 18 years of age - Pregnant women - Participants with anemia (Hgb<10 or Hct<30) - Participants with active medical conditions such as congestive heart failure or chronic lung disease requiring oxygen, active coronary artery disease with unstable angina, sepsis and renal failure - Participants with significant medical conditions, autoimmune disease or immunosuppression

Last updated:

6/10/2014

NCT ID:

NCT01796457

IRB Number:

11-000706