HBRN: Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B
This study is ongoing, but not recruiting participants.
Sponsor:
University of Pittsburgh
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Steven Belle, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01298037
First received: February 15, 2011
Last updated: May 27, 2016
Last verified: May 2016
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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 |
Resource links provided by NLM:
Further study details as provided by University of Pittsburgh:
Primary Outcome Measures:
- Immune regulatory and activation measures [ Time Frame: 240 weeks ] [ Designated as safety issue: No ]Immune regulatory and effector responses relative to HBV DNA, ALT and clinical outcome. HBV-specific lymphoproliferative, IFN-gamma and IL 10 responses, T cell activation and costimulatory markers (PD1, CTLA4, CD28, CD127), FoxP3+ Treg frequency, and NK frequency and expression of activating/inhibitory receptors and Dendritic cell frequency.
Biospecimen Retention: Samples Without DNA
Blood
| Enrollment: | 201 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | May 2020 |
| Estimated Primary Completion Date: | May 2020 (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 (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
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).
Criteria
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298037
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298037
Locations
| United States, California | |
| California Pacific Medical Center | |
| San Francisco, California, United States, 94107 | |
| University of California San Francisco Medical Center | |
| San Francisco, California, United States, 94143 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Minnesota | |
| University of Minnesota | |
| Plymouth, Minnesota, United States, 55446 | |
| Mayo Clinic Rochester | |
| Rochester, Minnesota, United States, 55905 | |
| United States, North Carolina | |
| University of North Carolina | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Texas | |
| University of Texas Southwestern | |
| Dallas, Texas, United States, 75390 | |
| United States, Virginia | |
| Virginia Commonwealth University | |
| Richmond, Virginia, United States, 23298 | |
| United States, Washington | |
| Virginia Mason Medical Center | |
| Seattle, Washington, United States, 98101 | |
| Harborview Medical Center | |
| Seattle, Washington, United States, 98104 | |
| Canada, Ontario | |
| University of Toronto | |
| Toronto, Ontario, Canada, ON M5G 1X8 | |
Sponsors and Collaborators
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
| Principal Investigator: | Kyong-Mi Chang, MD | University of Pennsylvania |
More Information
Additional Information:
| Responsible Party: | Steven Belle, Professor Department of Epidemiology, GSPH, 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: | May 27, 2016 |
| Health Authority: | United States: Federal Government |
| Individual Participant Data | |
| Plan to Share IPD: | No |
Keywords provided by University of Pittsburgh:
|
Immunology, Hepatitis B, HBV |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis B Hepatitis B, 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 September 30, 2016