A Study in Adult Subjects With Chronic Hepatitis B Infection to Support the Development of Immunological Assays
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 3
- 主要终点
- 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
研究概览
简要总结
The purpose of this study is to develop and characterize immunological assays on blood samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Any hepatitis B specific treatment prior to blood sampling at Visit
- •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
- •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.
结局指标
主要结局
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
时间窗: 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 CCR7 and/or CD62L
时间窗: 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 HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Frozen Samples
时间窗: 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 CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1
时间窗: 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 GITR and/or Ki67
时间窗: 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 CD39 and/or Tumor Necrosis Factor Receptor 2 (TNFR2)
时间窗: 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
时间窗: 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 HBs- and HBc-specific CD4+Foxp3- Expressing CD69 and/or LAP in Fresh Samples
时间窗: 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 CD4+Foxp3+ Expressing CD45RA and/or Glucocorticoid-induced Tumor Necrosis Factor Receptor-related Protein (GITR) and/or Proliferation Marker Ki67
时间窗: 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
时间窗: 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 CTLA4 and/or OX40
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples(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(At the time of the visit for each subject (i.e., Day 0))
- Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples(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(At the time of the visit for each subject (i.e., Day 0))