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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

This is an ancillary to the NIDDK-sponsored treatment trials titled: Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B (NCT01369212) and Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults With Chronic Hepatitis B (NCT01369199). This study will examine the balance between immune regulatory and effector responses in hepatitis B-infected participants enrolled in the HBRN's clinical trials (NCT01369212 and NCT01369199) to define natural history and treatment outcome.

Details

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.

Keywords

Hepatitis B Immunology HBV Immune tolerant Immune active

Eligibility

You can join if…

Open to people ages 18 years and up

  • Ability to provide informed consent for participation in the ancillary study

You CAN'T join if...

  • 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

Locations

  • California Pacific Medical Center
    San Francisco, California, 94115, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Pennsylvania
Links
Hepatitis B Research Network (HBRN) Website
ID
NCT01796457
Study Type
Observational
Last Updated
November 1, 2016