HBRN: Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B
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ClinicalTrials.gov Identifier: NCT01298037 |
Recruitment Status :
Active, not recruiting
First Posted : February 17, 2011
Last Update Posted : August 3, 2021
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Condition or disease |
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Hepatitis B |
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.
Study Type : | Observational |
Actual Enrollment : | 201 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | HBRN: Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B |
Study Start Date : | February 2011 |
Estimated Primary Completion Date : | July 2022 |
Estimated Study Completion Date : | July 2022 |

- Immune regulatory and activation measures [ Time Frame: 240 weeks ]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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01298037
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 |
Principal Investigator: | Kyong-Mi Chang, MD | University of Pennsylvania |
Responsible Party: | Kyong-Mi Chang, Professor, Gastroenterology, University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT01298037 |
Other Study ID Numbers: |
DK082864 HBRN Immunology U01DK082864 ( U.S. NIH Grant/Contract ) |
First Posted: | February 17, 2011 Key Record Dates |
Last Update Posted: | August 3, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Immunology, Hepatitis B, HBV |
Hepatitis A Hepatitis B Hepatitis B, Chronic Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections |
Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Hepadnaviridae Infections DNA Virus Infections Hepatitis, Chronic |