Immunologic TestsNCT01098006

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

A study testing Blood withdrawal in people with Immunologic Tests, run by GlaxoSmithKline at 2 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Immunologic Tests
What is being tested?: Blood withdrawal
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 99 participants
Where: 2 sitesBelgium
Study dates: 29 Apr 2010to 20 Feb 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 20Show fewer

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

Who cannot join

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).

Show all 15Show fewer

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.

Trial locations and contacts

2 sites in 1 country.

Belgium2 sites

GSK Investigational Site
Brussels, 1000
GSK Investigational Site
Brussels, 1070

Other trials in Belgium

About this study

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

Conditions: Immunologic Tests
Being tested: Blood withdrawal
Keywords: Immunological assays, Chronic hepatitis B
Medical subject headings: Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood withdrawalOther
A single blood sample was to be taken from all subjects at the study visit. No study-related treatment was given to the study participants.

Study groups in NCT01098006
Study group	Role	What they receive
Immune tolerant patients Group	Other	Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B viruss (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings. Receives: Other: Blood withdrawal
HBeAg positive Group	Other	HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with activee inflammation and varying degrees of liver fibbrosis. Receives: Other: Blood withdrawal
Inactive carriers Group	Other	Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis. Receives: Other: Blood withdrawal
HBeAg negative Group	Other	HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis. Receives: Other: Blood withdrawal

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1
The frequency was assessed based on the following range of markers: CD4, CD45RA, ICOS, HLA-DR, PD-1 and anti-Foxp3.
Measured: At the time of the visit for each subject (i.e., Day 0)
Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1
The frequency was assessed based on the following range of markers: CD4, CD45RA, ICOS, HLA-DR, PD-1 and anti-Foxp3.
Measured: At the time of the visit for each subject (i.e., Day 0)
Frequency of CD4+Foxp3+ Expressing CD45RA and/or Glucocorticoid-induced Tumor Necrosis Factor Receptor-related Protein (GITR) and/or Proliferation Marker Ki67
The frequency was assessed based on the following range of markers: CD4, CD45RA, GITR, anti-Foxp3 and Ki67.
Measured: At the time of the visit for each subject (i.e., Day 0)
Frequency of CD4+Foxp3- Expressing CD45RA and/or GITR and/or Ki67
The frequency was assessed based on the following range of markers: CD4, CD45RA, GITR, anti-Foxp3 and Ki67.
Measured: At the time of the visit for each subject (i.e., Day 0)
Frequency of CD4+Foxp3+ Expressing CD45RA and/or, Chemokine (C-C Motif) Receptor 7 (CCR7) and/or CD62L
The frequency was assessed based on the following range of markers: CD4, CD45RA, CCR7, CD62L and anti-Foxp3.
Measured: At the time of the visit for each subject (i.e., Day 0)
Frequency of CD4+Foxp3- Expressing CD45RA and/or CCR7 and/or CD62L
The frequency was assessed based on the following range of markers: CD4, CD45RA, CCR7, CD62L and anti-Foxp3.
Measured: At the time of the visit for each subject (i.e., Day 0)
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CD39 and/or Tumor Necrosis Factor Receptor 2 (TNFR2)
The frequency was assessed based on the following range of markers: CD4, CD45RA, CD39, TNFR2 and anti-Foxp3.
Measured: At the time of the visit for each subject (i.e., Day 0)
Frequency of CD4+Foxp3- Expressing CD45RA and/or CD39 and/or TNFR2
The frequency was assessed based on the following range of markers: CD4, CD45RA, CD39, TNFR2 and anti-Foxp3.
Measured: At the time of the visit for each subject (i.e., Day 0)
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CTLA4 and/or OX40
The frequency was assessed based on the following range of markers: CD4, CD45RA, CTLA4, OX40 and anti-Foxp3.
Measured: At the time of the visit for each subject (i.e., Day 0)
Frequency of CD4+Foxp3- Expressing CD45RA and/or CTLA4 and/or OX40
The frequency was assessed based on the following range of markers: CD4, CD45RA, CTLA4, OX40 and anti-Foxp3.
Measured: At the time of the visit for each subject (i.e., Day 0)
Frequency of HBs- and HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Fresh Samples
The frequency was assessed based on the following range of markers: CD4, CD69, LAP and anti-Foxp3.
Measured: At the time of the visit for each subject (i.e., Day 0)
Frequency of HBs- and HBc-specific CD4+Foxp3- Expressing CD69 and/or LAP in Fresh Samples
The frequency was assessed based on the following range of markers: CD4, CD69, LAP and anti-Foxp3.
Measured: At the time of the visit for each subject (i.e., Day 0)
Frequency of HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Frozen Samples
The frequency was assessed based on the following range of markers: CD4, CD69, LAP and anti-Foxp3.
Measured: At the time of the visit for each subject (i.e., Day 0)

Secondary outcomes (4)

Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
The frequency was assessed based on the following range of markers: CD4, CD40-L, IFNg, IL-2 and IL-17.
Note: The precision of the measure (i.e., four decimals) of median and inter-quartile range is not sufficient to distinguish between the values median, lower and upper limits of inter-quartile range for some of the data presented within the table below (e.g., median=0.0001 and inter-quartile range=0.0001 to 0.0001).
Measured: At the time of the visit for each subject (i.e., Day 0)
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
The frequency was assessed based on the following range of markers: CD8, CD40-L, IFNg, IL-2 and IL-17.
Note: The precision of the measure (i.e., four decimals) of median and inter-quartile range is not sufficient to distinguish between the values median, lower and upper limits of inter-quartile range for some of the data presented within the table below (e.g., median=0.0001 and inter-quartile range=0.0001 to 0.0001).
Measured: At the time of the visit for each subject (i.e., Day 0)
Frequency of CD4+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
The frequency was assessed based on the following range of markers: CD4, CD40-L, IFNg, IL-2 and IL-17.
Note: The precision of the measure (i.e., four decimals) of median and inter-quartile range is not sufficient to distinguish between the values median, lower and upper limits of inter-quartile range for some of the data presented within the table below (e.g., median=0.0001 and inter-quartile range=0.0001 to 0.0001).
Measured: At the time of the visit for each subject (i.e., Day 0)
Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
The frequency was assessed based on the following range of markers: CD8, CD40L, IFNg, IL-2 and IL-17.
Note: The precision of the measure (i.e., four decimals) of median and inter-quartile range is not sufficient to distinguish between the values median, lower and upper limits of inter-quartile range for some of the data presented within the table below (e.g., median=0.0001 and inter-quartile range=0.0001 to 0.0001).
Measured: At the time of the visit for each subject (i.e., Day 0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Apr 201020 Feb 2012

First posted2 Apr 2010 (estimated)
Study start29 Apr 2010
Primary completion20 Feb 2012
Study completion20 Feb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Immunologic TestsStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01098006
Sponsor's protocol ID: 113854
Status last verified: Feb 2020
First submitted: 1 Apr 2010
Last updated: 25 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
RecruitingPhase 1
Testing the Addition of an Anti-cancer Drug, Lenalidomide, to the Usual Combination Chemotherapy Treatment ("EPOCH") for Adult T-Cell Leukemia-Lymphoma (ATLL)
Acute Adult T-Cell Leukemia/Lymphoma, Adult T-Cell Leukemia/Lymphoma
Not yet recruiting
C2001P-CS3: Testing the Feasibility of Different HPV Screening and Care Strategies for Women Living With HIV
Human Papillomavirus (HPV), HPV Associated Cancers

All Immunologic Tests trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study in Adult Subjects With Chronic Hepatitis B Infection to Support the Development of Immunological Assays
ClinicalTrials.gov ID: NCT01098006
Acronym / sponsor ID: 113854
Conditions: Immunologic Tests
Keywords: Immunological assays, Chronic hepatitis B
Study type: Interventional
Recruitment status: Completed
Enrolment: 99 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 29 Apr 2010 (actual)
Primary completion: 20 Feb 2012 (actual)
Study completion: 20 Feb 2012 (actual)
First posted: 2 Apr 2010 (estimated)
Results: Posted 18 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Immune tolerant patients Group	Other	Other: Blood withdrawalImmune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B viruss (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
HBeAg positive Group	Other	Other: Blood withdrawalHBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with activee inflammation and varying degrees of liver fibbrosis.
Inactive carriers Group	Other	Other: Blood withdrawalInactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
HBeAg negative Group	Other	Other: Blood withdrawalHBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (20 listed)

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.

Key exclusion criteria (15 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Blood withdrawalA single blood sample was to be taken from all subjects at the study visit. No study-related treatment was given to the study participants.	Other	HBeAg negative Group, HBeAg positive Group, Immune tolerant patients Group, Inactive carriers Group

Primary outcome

Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1
Time frame: At the time of the visit for each subject (i.e., Day 0)
The frequency was assessed based on the following range of markers: CD4, CD45RA, ICOS, HLA-DR, PD-1 and anti-Foxp3.
Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1
Time frame: At the time of the visit for each subject (i.e., Day 0)
The frequency was assessed based on the following range of markers: CD4, CD45RA, ICOS, HLA-DR, PD-1 and anti-Foxp3.
Frequency of CD4+Foxp3+ Expressing CD45RA and/or Glucocorticoid-induced Tumor Necrosis Factor Receptor-related Protein (GITR) and/or Proliferation Marker Ki67
Time frame: At the time of the visit for each subject (i.e., Day 0)
The frequency was assessed based on the following range of markers: CD4, CD45RA, GITR, anti-Foxp3 and Ki67.
Frequency of CD4+Foxp3- Expressing CD45RA and/or GITR and/or Ki67
Time frame: At the time of the visit for each subject (i.e., Day 0)
The frequency was assessed based on the following range of markers: CD4, CD45RA, GITR, anti-Foxp3 and Ki67.
Frequency of CD4+Foxp3+ Expressing CD45RA and/or, Chemokine (C-C Motif) Receptor 7 (CCR7) and/or CD62L
Time frame: At the time of the visit for each subject (i.e., Day 0)
The frequency was assessed based on the following range of markers: CD4, CD45RA, CCR7, CD62L and anti-Foxp3.
Frequency of CD4+Foxp3- Expressing CD45RA and/or CCR7 and/or CD62L
Time frame: At the time of the visit for each subject (i.e., Day 0)
The frequency was assessed based on the following range of markers: CD4, CD45RA, CCR7, CD62L and anti-Foxp3.
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CD39 and/or Tumor Necrosis Factor Receptor 2 (TNFR2)
Time frame: At the time of the visit for each subject (i.e., Day 0)
The frequency was assessed based on the following range of markers: CD4, CD45RA, CD39, TNFR2 and anti-Foxp3.
Frequency of CD4+Foxp3- Expressing CD45RA and/or CD39 and/or TNFR2
Time frame: At the time of the visit for each subject (i.e., Day 0)
The frequency was assessed based on the following range of markers: CD4, CD45RA, CD39, TNFR2 and anti-Foxp3.
Frequency of CD4+Foxp3+ Expressing CD45RA and/or CTLA4 and/or OX40
Time frame: At the time of the visit for each subject (i.e., Day 0)
The frequency was assessed based on the following range of markers: CD4, CD45RA, CTLA4, OX40 and anti-Foxp3.
Frequency of CD4+Foxp3- Expressing CD45RA and/or CTLA4 and/or OX40
Time frame: At the time of the visit for each subject (i.e., Day 0)
The frequency was assessed based on the following range of markers: CD4, CD45RA, CTLA4, OX40 and anti-Foxp3.
Frequency of HBs- and HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Fresh Samples
Time frame: At the time of the visit for each subject (i.e., Day 0)
The frequency was assessed based on the following range of markers: CD4, CD69, LAP and anti-Foxp3.
Frequency of HBs- and HBc-specific CD4+Foxp3- Expressing CD69 and/or LAP in Fresh Samples
Time frame: At the time of the visit for each subject (i.e., Day 0)
The frequency was assessed based on the following range of markers: CD4, CD69, LAP and anti-Foxp3.
Frequency of HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Frozen Samples
Time frame: At the time of the visit for each subject (i.e., Day 0)
The frequency was assessed based on the following range of markers: CD4, CD69, LAP and anti-Foxp3.

4 secondary outcomes

Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples
Time frame: At the time of the visit for each subject (i.e., Day 0)
Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples
Time frame: At the time of the visit for each subject (i.e., Day 0)
Frequency of CD4+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
Time frame: At the time of the visit for each subject (i.e., Day 0)
Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples
Time frame: At the time of the visit for each subject (i.e., Day 0)

Results and safety

Results posted to the registry on 18 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Immune Tolerant Patients Group	7	7
HBeAg Positive Group	11	11
Inactive Carriers Group	60	60
HBeAg Negative Group	21	21

Primary outcome: Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1

Time frame: At the time of the visit for each subject (i.e., Day 0). Median (Inter-Quartile Range). Unit: Treg cells/million cells

Measure	Immune Tolerant Patients Group n = 4	HBeAg Positive Group n = 10	Inactive Carriers Group n = 56	HBeAg Negative Group n = 19
CD4+FOXP3+	5.025 (4.53 to 5.295)	6.275 (5.07 to 6.51)	4.185 (3.39 to 6.16)	4.93 (4 to 6.16)
CD4+FOXP3+CD45RA+	16.7 (8.53 to 28.9)	16 (9.79 to 29.1)	18 (14.4 to 29.25)	16.2 (10.4 to 25.4)
CD4+FOXP3+CD45RA+HLADR+ICOS+PD1-	0.1299 (0.0785 to 1.769)	0.0702 (0.0001 to 0.122)	0.1755 (0.07 to 0.3)	0.113 (0.0001 to 0.261)
CD4+FOXP3+CD45RA+HLADR+ICOS-PD1+	0.1191 (0.0001 to 0.2565)	0.119 (0.0747 to 0.134)	0.0762 (0.03 to 0.189)	0.0885 (0.0001 to 0.158)
CD4+FOXP3+CD45RA+HLADR+ICOS-PD1-	0.9705 (0.1534 to 1.95)	0.2905 (0.21 to 0.528)	0.51 (0.232 to 0.902)	0.388 (0.09 to 0.567)
CD4+FOXP3+CD45RA+HLADR-ICOS+PD1+	0.1836 (0.0001 to 0.4805)	0.0637 (0.0001 to 0.112)	0.106 (0.0339 to 0.227)	0.092 (0.0675 to 0.3)
CD4+FOXP3+CD45RA+HLADR-ICOS+PD1-	0.3915 (0.1665 to 0.9885)	0.356 (0.0747 to 0.725)	0.74 (0.244 to 1.43)	0.3185 (0.151 to 0.68)
CD4+FOXP3+CD45RA+HLADR-ICOS-PD1+	0.0723 (0.0327 to 0.1541)	0.1245 (0.0001 to 0.18)	0.0972 (0.0001 to 0.182)	0.138 (0.07 to 0.358)

Population analysed: The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.

Primary outcome: Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1

Time frame: At the time of the visit for each subject (i.e., Day 0). Median (Inter-Quartile Range). Unit: Treg cells/million cells

Measure	Immune Tolerant Patients Group n = 4	HBeAg Positive Group n = 10	Inactive Carriers Group n = 56	HBeAg Negative Group n = 19
CD4+FOXP3-	94.95 (94.7 to 95.45)	93.75 (93.6 to 94.9)	95.88 (93.8 to 96.61)	95 (93.8 to 96)
CD4+FOXP3-CD45RA+	38.7 (23.69 to 41.75)	44.3 (36.6 to 57.7)	33.9 (22.13 to 41.6)	30.2 (16.47 to 41.07)
CD4+FOXP3-CD45RA+HLADR+ICOS+PD1-	0.0995 (0.046 to 0.2155)	0.1103 (0.0519 to 0.167)	0.0853 (0.0346 to 0.1865)	0.0297 (0.004 to 0.115)
CD4+FOXP3-CD45RA+HLADR+ICOS-PD1+	0.2825 (0.127 to 0.4995)	0.1695 (0.123 to 0.369)	0.267 (0.109 to 0.983)	0.232 (0.147 to 0.857)
CD4+FOXP3-CD45RA+HLADR+ICOS-PD1-	1.53 (0.7938 to 1.68)	1.52 (0.951 to 3.3)	1.71 (0.406 to 2.805)	1.07 (0.424 to 1.89)
CD4+FOXP3-CD45RA+HLADR-ICOS+PD1+	0.0895 (0.0265 to 0.346)	0.0928 (0.0569 to 0.141)	0.0873 (0.0413 to 0.3565)	0.0976 (0.0273 to 0.598)
CD4+FOXP3-CD45RA+HLADR-ICOS+PD1-	1.33 (0.6668 to 3.695)	1.84 (0.48 to 3.52)	0.973 (0.325 to 2.895)	0.357 (0.0525 to 0.957)
CD4+FOXP3-CD45RA+HLADR-ICOS-PD1+	0.174 (0.1254 to 0.3645)	0.193 (0.0875 to 1.15)	0.2585 (0.126 to 4.37)	0.368 (0.0837 to 12.58)

Primary outcome: Frequency of CD4+Foxp3+ Expressing CD45RA and/or Glucocorticoid-induced Tumor Necrosis Factor Receptor-related Protein (GITR) and/or Proliferation Marker Ki67

Time frame: At the time of the visit for each subject (i.e., Day 0). Median (Inter-Quartile Range). Unit: Treg cells/million cells

Measure	Immune Tolerant Patients Group n = 4	HBeAg Positive Group n = 11	Inactive Carriers Group n = 55	HBeAg Negative Group n = 20
CD4+FOXP3+	5.335 (3.875 to 7.105)	5.82 (5.62 to 6.8)	4.68 (3.77 to 5.97)	5.37 (4.18 to 6.24)
CD4+FOXP3+CD45RA+	12.85 (11.2 to 22.2)	14.8 (5.9 to 32.8)	18.2 (13.6 to 27.34)	16.5 (8.58 to 29.3)
CD4+FOXP3+CD45RA+GITR+KI67-	0.2955 (0.0861 to 1.1145)	0.429 (0.211 to 0.571)	0.49 (0.269 to 0.74)	0.399 (0.288 to 0.599)
CD4+FOXP3+CD45RA+GITR-KI67+	0.0985 (0.0663 to 0.218)	0.2085 (0.12 to 0.564)	0.234 (0.14 to 0.448)	0.267 (0.07 to 0.452)
CD4+FOXP3+CD45RA+GITR-KI67-	12.55 (10.75 to 20.55)	13.8 (3.9 to 29.9)	17.7 (13.1 to 25.7)	15.4 (7.34 to 27.93)
CD4+FOXP3+CD45RA-GITR+KI67+	9.26 (7.055 to 11.05)	8.24 (4.47 to 10.4)	8.14 (6.32 to 11.32)	7.43 (5.09 to 9.56)
CD4+FOXP3+CD45RA-GITR+KI67-	35.65 (26.5 to 43.5)	33.4 (21.6 to 45.2)	27.34 (22.3 to 34.18)	28.8 (20 to 36.63)
CD4+FOXP3+CD45RA-GITR-KI67+	4.84 (3.44 to 7.11)	3.66 (2.58 to 5.58)	4.69 (3.88 to 6.77)	4.27 (3.67 to 6.19)

Primary outcome: Frequency of CD4+Foxp3- Expressing CD45RA and/or GITR and/or Ki67

Time frame: At the time of the visit for each subject (i.e., Day 0). Median (Inter-Quartile Range). Unit: Treg cells/million cells

Measure	Immune Tolerant Patients Group n = 4	HBeAg Positive Group n = 11	Inactive Carriers Group n = 55	HBeAg Negative Group n = 20
CD4+FOXP3-	94.65 (92.85 to 96.15)	94.2 (93.3 to 94.4)	95.31 (94 to 96.2)	94.65 (93.75 to 95.85)
CD4+FOXP3-CD45RA+	45.95 (42.8 to 49.25)	42.9 (29.4 to 56.5)	34.3 (26.7 to 44.3)	33.4 (24.295 to 43.4)
CD4+FOXP3-CD45RA+GITR+KI67-	0.6515 (0.4665 to 5.7485)	0.567 (0.359 to 0.891)	0.609 (0.27 to 2.23)	0.563 (0.3155 to 1.46)
CD4+FOXP3-CD45RA+GITR-KI67+	0.328 (0.226 to 0.393)	0.365 (0.332 to 0.685)	0.251 (0.142 to 0.404)	0.2275 (0.166 to 0.471)
CD4+FOXP3-CD45RA+GITR-KI67-	42.85 (36.6 to 48.25)	42.5 (27.8 to 55.2)	30.14 (14.15 to 41.1)	30.3 (19.95 to 37.9)
CD4+FOXP3-CD45RA-GITR+KI67+	1.0535 (0.583 to 1.38)	0.566 (0.472 to 0.974)	0.854 (0.528 to 1.46)	0.7955 (0.5645 to 1.27)
CD4+FOXP3-CD45RA-GITR+KI67-	13.35 (8.36 to 19.25)	12.6 (4.34 to 15.6)	12.94 (7.33 to 16.51)	13.225 (9.03 to 14.95)
CD4+FOXP3-CD45RA-GITR-KI67+	1.575 (1.405 to 2.05)	1.56 (1.25 to 2.44)	1.83 (1.29 to 2.24)	1.455 (1.053 to 2.175)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events (SAEs) related to study participation or to GSK concomitant products were collected during the study: from the time each subject consented to participate in the study up to study conclusion (i.e. during an approximate period of 22 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Immune Tolerant Patients Group	0 of 7 (0%)	0 of 0	0 of 7
HBeAg Positive Group	0 of 11 (0%)	0 of 0	0 of 11
Inactive Carriers Group	0 of 60 (0%)	0 of 0	0 of 60
HBeAg Negative Group	0 of 21 (0%)	0 of 0	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Immunologic Tests

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
RecruitingPhase 1
Testing the Addition of an Anti-cancer Drug, Lenalidomide, to the Usual Combination Chemotherapy Treatment ("EPOCH") for Adult T-Cell Leukemia-Lymphoma (ATLL)
Acute Adult T-Cell Leukemia/Lymphoma, Adult T-Cell Leukemia/Lymphoma
Not yet recruiting
C2001P-CS3: Testing the Feasibility of Different HPV Screening and Care Strategies for Women Living With HIV
Human Papillomavirus (HPV), HPV Associated Cancers

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Blood withdrawal in people with Immunologic Tests, run by GlaxoSmithKline at 2 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1 (time frame: At the time of the visit for each subject (i.e., Day 0)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01098006.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.