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

NCT ID: NCT01298037

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

201 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-01

Study Completion Date

2026-12-01

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Hepatitis B

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Kyong-Mi Chang

Professor, Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyong-Mi Chang, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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California Pacific Medical Center

San Francisco, California, United States

Site Status

University of California San Francisco Medical Center

San Francisco, California, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

University of Minnesota

Plymouth, Minnesota, United States

Site Status

Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

University of Texas Southwestern

Dallas, Texas, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Virginia Mason Medical Center

Seattle, Washington, United States

Site Status

Harborview Medical Center

Seattle, Washington, United States

Site Status

University of Toronto

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

Related Links

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http://www.hepbnet.org/

The Hepatitis B Research Network study web site

Other Identifiers

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U01DK082864

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK082864 HBRN Immunology

Identifier Type: -

Identifier Source: org_study_id

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