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

This study is currently recruiting participants.
Verified April 2013 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 21, 2013
Last verified: April 2013

February 19, 2013
June 21, 2013
March 2013
March 2016   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01796457 on ClinicalTrials.gov Archive Site
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HBRN: Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of Chronic Hepatitis B
HBRN: Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of Chronic Hepatitis B

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.

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.

Observational
Time Perspective: Prospective
Not Provided
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 clinical trials (NCT01369212 or NCT01369199).

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
190
March 2018
March 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

-

Exclusion Criteria:

  • Children under 18 years of age, participants with anemia
  • Anemia with Hgb<10 or Hct<30 and 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
Both
18 Years and older
No
Contact: Mary Valiga, RN 215-823-5800 Ext. 6726 mevaliga@mail.med.upenn.edu
United States,   Canada
 
NCT01796457
DK082864 Immunology Treatment, 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
April 2013

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