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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01796457
• Other study ID #: DK082864 Immunology Treatment
• Secondary ID: U01DK082864
• Status: Active, not recruiting
• Start date: March 2013
• Est. completion date: December 1, 2024

Study information

• Verified date: September 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Locations

Country	Name	City	State
Canada	Toronto Western Hospital Liver Centre	Toronto	Ontario
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	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 effector responses relative to HBV DNA, ALT and clinical outcome	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	up to 192 weeks