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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01298037
Other study ID # DK082864 HBRN Immunology
Secondary ID U01DK082864
Status Active, not recruiting
Phase
First received
Last updated
Start date February 1, 2011
Est. completion date December 1, 2024

Study information

Verified date January 2024
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 201
Est. completion date December 1, 2024
Est. primary completion date December 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada University of Toronto Toronto Ontario
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States University of North Carolina Chapel Hill North Carolina
United States University of Texas Southwestern Dallas Texas
United States University of Minnesota Plymouth Minnesota
United States Virginia Commonwealth University Richmond Virginia
United States Mayo Clinic Rochester Rochester Minnesota
United States California Pacific Medical Center San Francisco California
United States University of California San Francisco Medical Center San Francisco California
United States Harborview Medical Center Seattle Washington
United States Virginia Mason Medical Center Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Pennsylvania National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Immune regulatory and activation measures 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. 240 weeks
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