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
  Purpose

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


Condition Intervention Phase
Immunologic Tests
Hepatitis B Infection
Other: Blood withdrawal
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Study in Adult Subjects With Chronic Hepatitis B Infection to Support the Development of Immunological Assays

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 99
Study Start Date: April 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A
Other: no treatment Immune tolerant patients
Other: Blood withdrawal
Blood sampling
Group B
Other: no treatment HBeAg (Hepatitis B envelope antigen) positive chronic hepatitis B patients
Other: Blood withdrawal
Blood sampling
Group C
Other: no treatment Healthy carriers
Other: Blood withdrawal
Blood sampling
Group D
Other: no treatment HBeAg negative chronic hepatitis B patients
Other: Blood withdrawal
Blood sampling

Detailed Description:

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01098006

Locations
Belgium
GSK Investigational Site
Brussels, Belgium, 1070
GSK Investigational Site
Bruxelles, Belgium, 1000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01098006     History of Changes
Other Study ID Numbers: 113854
Study First Received: April 1, 2010
Last Updated: July 19, 2012
Health Authority: Belgium: Agence Fédérale des Médicaments et des Produits de la Santé

Keywords provided by GlaxoSmithKline:
Immunological assays
Chronic hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Infection
Communicable Diseases
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 29, 2014