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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.
Aim 1. Therapeutic HBV suppression will enhance antiviral immune effector responses and reduce immune inhibitory factors in participants with chronic hepatitis B. This study will also examine if antiviral therapy has a durable effect in host immune phenotype and define the immunological effect of interferon-alpha (IFNα) therapy in chronic HBV participants. Aim 2. Antiviral immune effector and regulatory responses before, during and/or after therapy can predict long term therapeutic response.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
California Pacific Medical Center
San Francisco, California, United States
University of California San Francisco Medical Center
San Francisco, California, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Minnesota
Plymouth, Minnesota, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
Toronto Western Hospital Liver Centre
Toronto, Ontario, Canada
Start Date
March 1, 2013
Primary Completion Date
December 1, 2026
Completion Date
December 1, 2026
Last Updated
January 22, 2026
40
ACTUAL participants
Lead Sponsor
University of Pennsylvania
Collaborators
NCT07024641
NCT06671093
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07275554