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

Sponsor

University of Pennsylvania (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01298037

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

201

Enrollment

Locations

148.9

Duration (Months)

16.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Hepatitis B

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.

Study Design

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 :

Feb 1, 2011

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Outcome Measures

Primary Outcome Measures

Immune regulatory and activation measures [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	California Pacific Medical Center	San Francisco	California	United States	94107
2	University of California San Francisco Medical Center	San Francisco	California	United States	94143
3	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
4	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02115
5	University of Minnesota	Plymouth	Minnesota	United States	55446
6	Mayo Clinic Rochester	Rochester	Minnesota	United States	55905
7	University of North Carolina	Chapel Hill	North Carolina	United States	27599
8	University of Texas Southwestern	Dallas	Texas	United States	75390
9	Virginia Commonwealth University	Richmond	Virginia	United States	23298
10	Virginia Mason Medical Center	Seattle	Washington	United States	98101
11	Harborview Medical Center	Seattle	Washington	United States	98104
12	University of Toronto	Toronto	Ontario	Canada	ON M5G 1X8