HBRN: Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of Chronic Hepatitis B
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/28/2018 |
| Start Date: | March 2013 |
| End Date: | July 2020 |
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.
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.
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.
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.
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
We found this trial at
8
sites
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Virginia Commonwealth University Medical Center The Virginia Commonwealth University Health System is an urban, comprehensive...
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California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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505 Parnassus Ave
San Francisco, California 94143
San Francisco, California 94143
(415) 476-1000
University of California, San Francisco Medical Center UCSF Medical Center is recognized throughout the world...
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Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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