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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01796457
First received: February 19, 2013
Last updated: January 27, 2016
Last verified: January 2016
  Purpose

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.


Condition
Hepatitis B

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: HBRN: Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of Chronic Hepatitis B

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Immune regulatory and effector responses relative to HBV DNA, ALT and clinical outcome [ Time Frame: up to 192 weeks ] [ Designated as safety issue: No ]
    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


Biospecimen Retention:   Samples Without DNA
Blood

Enrollment: 40
Study Start Date: March 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will be recruited from multi-site clinical centers in the United States and Canada including primary care hospitals and community centers that have enrolled into the HBRN clinical trials (NCT01369212 or NCT01369199).
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01796457

Locations
United States, California
California Pacific Medical Center
San Francisco, California, United States, 94115
University of California San Francisco Medical Center
San Francisco, California, United States, 94143
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
United States, Minnesota
University of Minnesota
Plymouth, Minnesota, United States, 55446
United States, Virginia
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Harborview Medical Center
Seattle, Washington, United States, 98104
Canada, Ontario
Toronto Western Hospital Liver Centre
Toronto, Ontario, Canada
Sponsors and Collaborators
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Kyong-Mi Chang, MD University of Pennsylvania
  More Information

Additional Information:
No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01796457     History of Changes
Other Study ID Numbers: DK082864 Immunology Treatment  U01DK082864 
Study First Received: February 19, 2013
Last Updated: January 27, 2016
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Hepatitis B
Immunology
HBV
Immune tolerant
Immune active

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on February 11, 2016