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

Active, not recruiting

• Conditions: Hepatitis B

• Registration Number: NCT01298037
• Lead Sponsor: University of Pennsylvania

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).

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-02-01
• Study First Submitted: 2011-02-15
• Study First Submitted QC: 2011-02-16
• Study First Posted: 2011-02-17
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

• Providing informed consent for this ancillary study.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (12)

University of Minnesota; 🇺🇸 Plymouth, Minnesota, United States

University of California San Francisco Medical Center; 🇺🇸 San Francisco, California, United States

California Pacific Medical Center; 🇺🇸 San Francisco, California, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States

University of Texas Southwestern; 🇺🇸 Dallas, Texas, United States

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

University of Toronto; 🇨🇦 Toronto, Ontario, Canada