Trial record 2 of 2 for:    NCT01263587

HBRN: Immune Regulation and Costimulation in Natural History 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:
NCT01298037
First received: February 15, 2011
Last updated: June 10, 2014
Last verified: June 2014

February 15, 2011
June 10, 2014
February 2011
May 2015   (final data collection date for primary outcome measure)
Immune regulatory and activation measures [ Time Frame: 240 weeks ] [ Designated as safety issue: No ]
Immune regulatory and effector responses relative to HBV DNA, ALT and clinical outcome. HBV-specific lymphoproliferative, IFN-gamma and IL 10 responses, T cell activation and costimulatory markers (PD1, CTLA4, CD28, CD127), FoxP3+ Treg frequency, and NK frequency and expression of activating/inhibitory receptors and Dendritic cell frequency.
Immune regulatory and activation measures [ Time Frame: 240 weeks ] [ Designated as safety issue: No ]
%FoxP3+ Tregs, T cell expression of PD1/CTLA4 and/or HBV-specific IL10+ Tr1 response, NKG2D, CD69, HBV-specific T cell and dendritic cell interferon response
Complete list of historical versions of study NCT01298037 on ClinicalTrials.gov Archive Site
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HBRN: Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B
HBRN: Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B

This is an ancillary to the NIDDK-sponsored Hepatitis B Research Network (HBRN) Study Cohort Study NCT01263587. This study will examine the balance between immune regulatory and effector responses in hepatitis B-infected participants enrolled in the HBRN study (NCT01263587).

Aim 1: The clinical and virological status of chronic Hepatitis B (HBV) infection is defined by distinct patterns of immune effector and regulatory responses: The investigators propose that one or more immune regulatory are induced during chronic hepatitis B that define the extent of immune tolerance vs. activation with associated disease activity and viremia. Towards this end, the immune effector and regulatory responses relative to serum HBV DNA, alanine aminotransferase (ALT), Hepatitis B e antigen (HBeAg), Hepatitis B surface antigen (HBsAg) and liver histology will be examined in a cross-sectional manner in patients with chronic HBV and control groups.

Aim 2: Clinical hepatitis flares during chronic hepatitis B reflect altered balance between immune regulatory and effector responses.

Observational
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

Blood

Non-Probability Sample

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 cohort study (NCT01263587).

Hepatitis B
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
May 2015
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

• Providing informed consent for this ancillary study.

Exclusion Criteria:

  • Children under 18 years of age, participants with anemia
  • Hgb<10 or Hct<30, congestive heart failure or chronic lung disease requiring oxygen, active coronary artery disease with unstable angina, sepsis or renal failure, other significant medical conditions, autoimmune disease or immunosuppression.
Both
18 Years and older
Yes
Contact: Mary Valiga, RN 215-823-5800 ext 6726 mevaliga@mail.med.upenn.edu
United States,   Canada
 
NCT01298037
DK082864 HBRN Immunology, U01DK082864
Yes
University of Pittsburgh
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Kyong-Mi Chang, MD University of Pennsylvania
University of Pittsburgh
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP