Trial record 2 of 2 for:    NCT01369212

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01796457
First received: February 19, 2013
Last updated: June 10, 2014
Last verified: June 2014
  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


Estimated Enrollment: 165
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

Contacts
Contact: Mary Valiga, RN 215-823-5800 Ext. 6726 mevaliga@mail.med.upenn.edu

Locations
United States, California
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94115
Contact: Stewart Cooper, MD    415-600-1548    scooper@cpmcri.org   
University of California San Francisco Medical Center Not yet recruiting
San Francisco, California, United States, 94143
Contact: Norah Terrault, MD,MPH    415-476-2227    norah.terrault@ucsf.edu   
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Ray Chung, MD    617-724-7562    rtchung@partners.org   
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: Daryl Lau, MD    617-632-1098    dlau@bidmc.harvard.edu   
United States, Minnesota
University of Minnesota Not yet recruiting
Plymouth, Minnesota, United States, 55446
Contact: Coleman Smith, MD    612-871-1145 ext 2908    smith146@umn.edu   
Mayo Clinic Rochester Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Lewis R. Roberts, MB, ChB, PhD    507-538-4877    roberts.lewis@mayo.edu   
United States, Texas
University of Texas Southwestern Not yet recruiting
Dallas, Texas, United States, 75390
Contact: William Lee, MD    214-645-6110    william.lee@utsouthwestern.edu   
United States, Virginia
Virginia Commonwealth University Medical Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Richard Sterling, MD    804-828-4060    rksterli@vcu.edu   
United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Robert Carithers, MD    206-598-4956    robertc@medicine.washington.edu   
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Kris Kowdley, MD    206-223-2319    kkowdley@benaroyaresearch.org   
Canada, Ontario
Toronto Western Hospital Liver Centre Not yet recruiting
Toronto, Ontario, Canada
Contact: Harry Janssen, MD, PhD    416-603-5800 ext 2776    harry.janssen@uhn.edu   
Sponsors and Collaborators
University of Pittsburgh
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: June 10, 2014
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, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on September 30, 2014