A Study in Adult Subjects With Chronic Hepatitis B Infection to Support the Development of Immunological Assays

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01098006
First received: April 1, 2010
Last updated: July 19, 2012
Last verified: July 2012

April 1, 2010
July 19, 2012
April 2010
February 2012   (final data collection date for primary outcome measure)
  • Frequency of Hepatitis B (HB) antigen-specific regulatory T (Treg) cells. [ Time Frame: At Day 1 ] [ Designated as safety issue: No ]
  • Presence of HB antigen-specific Treg cells in cryopreserved and fresh blood samples from the same donor. [ Time Frame: At Day 1 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01098006 on ClinicalTrials.gov Archive Site
  • Frequency of IL-17 positive T-cells. [ Time Frame: At Day 1 ] [ Designated as safety issue: No ]
  • Frequency of Th1 positive T-cells. [ Time Frame: At Day 1 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study in Adult Subjects With Chronic Hepatitis B Infection to Support the Development of Immunological Assays
A Study in Adult Subjects With Chronic Hepatitis B Infection to Support the Development of Immunological Assays

The purpose of this study is to develop and characterize immunological assays on blood samples.

Chronic hepatitis B patients of the following 4 groups will be asked to participate in the study:

  • Group A: Immune tolerant patients
  • Group B: Hepatitis B envelope antigen (HBeAg)-positive chronic hepatitis B patients
  • Group C: Healthy carriers
  • Group D: Hepatitis B envelope antigen (HBeAg)-negative chronic hepatitis B patients
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
  • Immunologic Tests
  • Hepatitis B Infection
Other: Blood withdrawal
Blood sampling
  • Group A
    Other: no treatment Immune tolerant patients
    Intervention: Other: Blood withdrawal
  • Group B
    Other: no treatment HBeAg (Hepatitis B envelope antigen) positive chronic hepatitis B patients
    Intervention: Other: Blood withdrawal
  • Group C
    Other: no treatment Healthy carriers
    Intervention: Other: Blood withdrawal
  • Group D
    Other: no treatment HBeAg negative chronic hepatitis B patients
    Intervention: Other: Blood withdrawal
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
February 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Written informed consent obtained from the subject.
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • A male or female between, and including, 18 and 65 years of age at study start.
  • Evidence of chronic hepatitis B infection as per medical record.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 day prior to study start.

In addition to these general inclusion criteria, subjects should satisfy ALL specific criteria according to the specified group maximum 6 months prior to Visit 1 as per medical records:

Group A: Immune tolerant patients

  • Viral load: > 2x107 IU/mL of HBV DNA
  • HBeAg positive
  • Normal levels of ALT according to lab range Group B: HBeAg positive chronic hepatitis B patients
  • Viral load: > 2x104 IU/mL of HBV DNA
  • HBeAg positive
  • Increased levels of ALT and/or evidence of chronic hepatitis on liver biopsy Group C: Healthy carriers
  • Viral load: not exceeding 2x103 IU/mL of HBV DNA
  • HBeAg negative
  • Normal levels of ALT measured at least twice, at least 3 months apart, during the last 6 months Group D: HBeAg negative chronic hepatitis B patients
  • Viral load: > 2x103 IU/mL of HBV DNA
  • HBeAg negative
  • Increased levels of ALT and/or evidence of chronic hepatitis on liver biopsy

Exclusion Criteria:

  • Any hepatitis B specific treatment prior to blood sampling at Visit 1.
  • Any known clinically significant anaemia or any other condition within 7 days prior to study entry (Visit 1) as per medical records that would preclude the drawing of blood as described in the protocol.
  • Receipt of live attenuated vaccines within 30 days preceding the blood sampling at Visit 1 and the administration of a pandemic influenza vaccine within 21 days preceding the blood sampling at Visit 1.
  • Receipt of blood products within 120 days prior to study entry (Visit 1).
  • Receipt of immunoglobulins within 120 days prior to study entry (Visit 1).
  • Receipt of interferon within 120 days prior to study entry (Visit 1).
  • Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding study start, or planned use during the study period.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • History of immunosuppressive or immune-mediated disorders including autoimmune diseases, human immunodeficiency virus (HIV) infection and hepatitis C infection, based on medical history and physical examination (no laboratory testing required).
  • Pregnant or lactating female.
  • History of malignancy (unless there has been surgical excision followed by a sufficient observation period, of at least 5 years, to give a reasonable assurance of sustained cure and which, in the estimate of the investigator, is not likely to recur during the study period).
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs (including chloroquine) within six months prior to the blood sampling at Visit 1 (for corticosteroids, this will mean prednisone ≥10 milligram/day (10 mg/day), or equivalent). Inhaled and topical steroids are allowed.
  • History of type I or type II diabetes mellitus including cases controlled with diet alone (a subject with past gestational diabetes is eligible).
  • History of major congenital defect.
  • Subjects with a history of, or current, alcohol or substance abuse.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01098006
113854
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
July 2012

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