NCT02498275终止不适用
Effect of RO6871765 and RO7011785 on Immune Response With the Stimulation of Peripheral Blood Mononuclear Cells (PBMCs) in Chinese Healthy Volunteers and Chronic Hepatitis B Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 主要终点
- Cytokine/chemokine production
研究概览
简要总结
This is an exploratory study to characterize the ex vivo immune response to RO6871765 or RO7011785 stimulation of peripheral blood mononuclear cells (PBMCs) extracted from healthy volunteers and chronic hepatitis B (CHB) patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- 是
入选标准
- •All population:
- •Chinese population
- •Adequate hematological function: platelet count greater than or equal to (>=) 100*10^9 per liter (/L), hemoglobin (Hb) >= 12 grams/deciliter (g/dL) (male) or >= 11 g/dL (female), white blood cell (WBC) count >= 4*10^9/L and <= 11*10^9/L
- •Healthy volunteers:
- •Absence of evidence of any active or chronic disease
- •Negative hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B envelope antigen (HBeAg), hepatitis B envelope antiody (HBeAb) and hepatitis B core antibody (HBcAb)
- •Adequate liver function: transaminases alanine aminotransferase (ALT) <= 1.0 times the upper limit of normal (ULN)
- •Treatment naïve CHB patients:
- •HBsAg-positive (>=250 international unit/milliliter [IU/mL]), compensated liver function, non-cirrhotic
- •HBeAg-positive, HBV DNA >= 200,000 IU/ml or equivalent copies/mL, ALT >1.5 times the ULN and ALT <8 times the ULN
- •HBeAg-negative nucleoside/nucleotide analogue-treated CHB patients:
- •Subjects who HBeAg-seroconverted on nucleoside/nucleotide analogue therapy (treatment for 1 to 3 years prior to enrollment) with HBV DNA <90 IU/mL or below a detection level acceptable by both the sponsor and investigator for at least the preceding 6 months; HBeAg negative and HBeAb positive
- •HBsAg-positive (>=250 IU/mL), compensated liver function, non-cirrhotic -ALT <= 1*ULN
排除标准
- •Use of steroids or other immune suppressive agents within the last 4 weeks that would impact the number/functions of white blood cells (WBC)
- •Any other diseases or clinical laboratory finding giving reasonable suspicion of a disease or condition (including, but not limited to, cancer, lupus erythematosus, rheumatoid arthritis, or other autoimmune disease) that could confound the result of the study
- •Positive Hepatitis A immunoglobulin M (IgM) antibody, Hepatitis C antibody (HCV Ab) or human immunodeficiency virus (HIV) at screening
- •Significant acute infection, example; influenza, acute gastrointestinal symptoms or any other clinically significant illness within 2 weeks
- •Previous/concurrent treatment with interferon-based therapy for CHB
结局指标
主要结局
Cytokine/chemokine production
时间窗: Day 1
Induction of interferon-responsive genes
时间窗: Day 1
Correlation coefficients between baseline toll-like receptor 7 (TLR7) expression and ex vivo immune response upon stimulation of PBMCs with RO6871765 or RO7011785 (in terms of cytokine release and gene expression)
时间窗: Day 1
次要结局
- Number or percentages of B-lymphocytes in healthy volunteers and subjects with CHB(Screening up to Day 1)
- Number or percentages of myeloid dendritic cells (mDCs) in healthy volunteers and subjects with CHB(Screening up to Day 1)
- Ex-vivo antiviral activity of PBMC supernatant(Day 1)
- Number or percentages of T-lymphocytes in healthy volunteers and subjects with CHB(Screening Up to Day 1)
- Number or percentages of natural killer (NK) -cells in healthy volunteers and subjects with CHB(Screening up to Day 1)
- Number or percentages of plasmacytoid dendritic cells (pDCs) in healthy volunteers and subjects with CHB(Screening up to Day 1)
研究者
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