HBRN: Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
First received: February 15, 2011
Last updated: January 6, 2016
Last verified: October 2015
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).

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

Estimated Enrollment: 300
Study Start Date: February 2011
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Detailed Description:

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.


Ages Eligible for Study:   18 Years and older
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).

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

Contact: Mary Valiga, RN 215-823-5800 ext 6726 mevaliga@mail.med.upenn.edu

United States, California
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94107
Contact: Stewart Cooper, MD    415-600-1530    coopersl@sutterhealth.org   
Contact    415-600-1020      
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   
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: Mohamed Hassan, MD    612-625-8999    hassan042@umn.edu   
Contact    612-626-1716      
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Lewis R. Roberts, MB, ChB, Phd    507-538-4877    roberts.lewis@mayo.edu   
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Michael Fried, MD    919-966-2516    mfried@med.unc.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
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Chia Wang, MD, MS    206-341-1452    chia.wang@vmms.org   
Contact    206-341-1021      
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Robert Carithers, MD    206-598-4956    doctorc@u.washington.edu   
Canada, Ontario
University of Toronto Recruiting
Toronto, Ontario, Canada, ON M5G 1X8
Contact: Harry Janssen, MD, PhD    416-603-5800 ext 2776    harry.janssen@uhn.ca   
Sponsors and Collaborators
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Kyong-Mi Chang, MD University of Pennsylvania
  More Information

Additional Information:
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: January 6, 2016
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 A
Hepatitis, Chronic
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 30, 2016