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

NCT ID: NCT01796457

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

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2026-12-01

Brief Summary

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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.

Detailed Description

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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.

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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

University of Minnesota

Plymouth, Minnesota, United States

Site Status

Virginia Commonwealth University Medical Center

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

Toronto Western Hospital Liver Centre

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

Related Links

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Other Identifiers

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U01DK082864

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK082864 Immunology Treatment

Identifier Type: -

Identifier Source: org_study_id

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