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

NCT01796457 · tracked via the Priya Life Science Canada tracker

Sponsor

University of Pennsylvania

Phase

Observational

Started

2013-03

Last updated

2026-01-22

Condition(s) studied

Hepatitis B

Study summary

This is an ancillary to the NIDDK-sponsored treatment trials titled: Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B (NCT01369212) and Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults With Chronic Hepatitis B (NCT01369199).

This study will examine the balance between immune regulatory and effector responses in hepatitis B-infected participants enrolled in the HBRN's clinical trials (NCT01369212 and NCT01369199) to define natural history and treatment outcome.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Ability to provide informed consent for participation in the ancillary study Exclusion Criteria: * Children under 18 years of age * Pregnant women * Participants with anemia (Hgb\<10 or Hct\<30) * Participants with active medical conditions such as congestive heart failure or chronic lung disease requiring oxygen, active coronary artery disease with unstable angina, sepsis and renal failure * Participants with significant medical conditions, autoimmune disease or immunosuppression

Primary outcome measure(s)

Immune regulatory and effector responses relative to HBV DNA, ALT and clinical outcome — up to 192 weeks
HBV-specific lymphoproliferative, IFN-gamma and IL10 responses, T cell activation and costimulatory markers ( PD1, CTLA4, CD28, CD127), FoxP3+ Treg frequency, and NK frequency and expression of activating/inhibitory receptors Dendritic cell frequency

Trial sites (8)

Facility	City	Region
California Pacific Medical Center	San Francisco	California
University of California San Francisco Medical Center	San Francisco	California
Beth Israel Deaconess Medical Center	Boston	Massachusetts
University of Minnesota	Plymouth	Minnesota
Virginia Commonwealth University Medical Center	Richmond	Virginia
Virginia Mason Medical Center	Seattle	Washington
Harborview Medical Center	Seattle	Washington
Toronto Western Hospital Liver Centre	Toronto	Ontario

More University of Pennsylvania trials in Canada

Longitudinal Study for Eosinophilic Granulomatosis With Polyangiitis Recruiting

A Randomized Multicenter Study for Isolated Skin Vasculitis Recruiting

Abatacept for the Treatment of Giant Cell Arteritis Recruiting

One-Time DNA Study for Vasculitis Recruiting

HBRN: Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B Active, not recruiting

Other trials for the same condition

A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB) Active, not recruiting

Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus) Active, not recruiting

HBRN: Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B Active, not recruiting

Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01796457 on ClinicalTrials.gov ↗ ← All trials in Canada