HBRN: Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B
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Purpose
This is an ancillary to the NIDDK-sponsored Hepatitis B Research Network (HBRN) Study Cohort Study NCT01263587. This study will examine the balance between immune regulatory and effector responses in hepatitis B-infected participants enrolled in the HBRN study (NCT01263587).
| Condition |
|---|
|
Hepatitis B |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | HBRN: Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B |
- Immune regulatory and activation measures [ Time Frame: 240 weeks ] [ Designated as safety issue: No ]%FoxP3+ Tregs, T cell expression of PD1/CTLA4 and/or HBV-specific IL10+ Tr1 response, NKG2D, CD69, HBV-specific T cell and dendritic cell interferon response
Biospecimen Retention: Samples Without DNA
Blood
| Estimated Enrollment: | 300 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
Aim 1: The clinical and virological status of chronic Hepatitis B (HBV) infection is defined by distinct patterns of immune effector and regulatory responses: The investigators propose that one or more immune regulatory are induced during chronic hepatitis B that define the extent of immune tolerance vs. activation with associated disease activity and viremia. Towards this end, the immune effector and regulatory responses relative to serum HBV DNA, alanine aminotransferase (ALT), Hepatitis B e antigen (HBeAg), Hepatitis B surface antigen (HBsAg) and liver histology will be examined in a cross-sectional manner in patients with chronic HBV and control groups.
Aim 2: Clinical hepatitis flares during chronic hepatitis B reflect altered balance between immune regulatory and effector responses.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
The study population will be recruited from multi-site clinical centers in the United States and Canada including primary care hospitals and community centers that have enrolled into the HBRN cohort study (NCT01263587).
Inclusion Criteria:
• Providing informed consent for this ancillary study.
Exclusion Criteria:
- Children under 18 years of age, participants with anemia
- Hgb<10 or Hct<30, congestive heart failure or chronic lung disease requiring oxygen, active coronary artery disease with unstable angina, sepsis or renal failure, other significant medical conditions, autoimmune disease or immunosuppression.
Contacts and Locations| Contact: Mary Valiga, RN | 215-823-5800 ext 6726 | mevaliga@mail.med.upenn.edu |
| United States, California | |
| University of California San Francisco Medical Center | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Norah Terrault, MD,MPH 415-476-2227 norah.terrault@ucsf.edu | |
| California Pacific Medical Center | Recruiting |
| San Francisco, California, United States, 94107 | |
| Contact: Stewart Cooper, MD 415-600-1548 coopersl@sutterhealth.org | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Ray Chung, MD 617-724-7562 rtchung@partners.org | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Daryl Lau, MD 617-632-1098 dlau@bidmc.harvard.edu | |
| United States, Minnesota | |
| University of Minnesota | Recruiting |
| Plymouth, Minnesota, United States, 55446 | |
| Contact: Coleman Smith, MD 612-871-1145 ext 2908 smith146@umn.edu | |
| Mayo Clinic Rochester | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Kim W. Ray, MD 507-538-0254 | |
| United States, North Carolina | |
| University of North Carolina | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Micheal Fried, MD 919-966-2516 mfried@med.unc.edu | |
| United States, Pennsylvania | |
| University of Pittsburgh | Not yet recruiting |
| Pittsburgh, Pennsylvania, United States, 15261 | |
| Contact: Steven Belle, PhD 412-624-3758 belle@edc.pitt.edu | |
| United States, Texas | |
| University of Texas Southwestern | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: William Lee, MD 214-645-6110 william.lee@utsouthwestern.edu | |
| United States, Virginia | |
| Virginia Commonwealth University | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Richard Sterling, MD 804-828-4060 rksterli@vcu.edu | |
| United States, Washington | |
| University of Washington Medical Center | Recruiting |
| Seattle, Washington, United States, 98195 | |
| Contact: Robert Carithers, MD 206-598-4956 doctorc@u.washington.edu | |
| Virginia Mason Medical Center | Recruiting |
| Seattle, Washington, United States, 98101 | |
| Contact: Kris Kowdley, MD 206-223-2319 kkowdley@benaroyaresearch.org | |
| Canada, Ontario | |
| University of Toronto | Recruiting |
| Toronto, Ontario, Canada, ON M5G 1X8 | |
| Contact: Jenny Heathcote, MD 416-603-5914 jenny.heathcote@utoronto.ca | |
| Principal Investigator: | Kyong-Mi Chang, MD | University of Pennsylvania |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT01298037 History of Changes |
| Other Study ID Numbers: | DK082864 HBRN Immunology, U01DK082864 |
| Study First Received: | February 15, 2011 |
| Last Updated: | April 8, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Pittsburgh:
|
Immunology, Hepatitis B, HBV |
Additional relevant MeSH terms:
|
Hepatitis B Hepatitis B, Chronic Hepatitis Hepatitis A Hepatitis, Chronic Liver Diseases Digestive System Diseases |
Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections |
ClinicalTrials.gov processed this record on May 19, 2013