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

Active, not recruiting

• Conditions: Hepatitis B

• Registration Number: NCT01796457
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-02-19
• Study First Submitted QC: 2013-02-19
• Study First Posted: 2013-02-21
• Study Start: 2013-03
• Status Verified: 2023-09
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-10
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Ability to provide informed consent for participation in the ancillary study

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (8)

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

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

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

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

Toronto Western Hospital Liver Centre; 🇨🇦 Toronto, Ontario, Canada

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

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

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