NCT01205087已完成2 期
Safety and Efficacy of Oral Administration of Anti-CD3 Monoclonal Antibody in Patients With the Metabolic Syndrome PHASE IIa A Single-blinded Placebo-controlled Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- This clinical study is designed to evaluate the safety and the immune-modulatory effects of oral administration of the study drug anti-CD3 MAb to subjects with the metabolic syndrome.
研究概览
简要总结
This clinical study is designed to evaluate the safety and immune modulatory effects of oral administration of the study drug anti-CD3 monoclonal antibody (MAb) to subjects with the metabolic syndrome.
详细描述
PHASE IIa STUDY PROTOCOL A Single-blinded Placebo-controlled Clinical Trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have completed the informed consent process culminating with written informed consent by the subject.
- •Men and women age 18 to 75 years (inclusive)
- •Patients with biopsy proven NASH within the last 3 years
- •Altered glucose metabolism, including diabetes (non treated, or treated with up to 2 drugs (not including insulin) without any change in medication for at least 2 months prior to enrollment), impaired fasting glucose or impaired glucose tolerance.
- •HBA1C between 5.5 and 14%.
排除标准
- •Subjects who have undergone surgery within the last 3 months.
- •Subjects who have had a prior gastrointestinal surgery.
- •Subjects with a clinically significant infectious, immune mediated or malignant disease
- •Subjects who are receiving an elemental diet or parenteral nutrition.
- •Subjects who have been treated with any type of immune modulatory drug including steroids or NSAID within the last 4 weeks
- •Subjects who have received either methotrexate or cyclosporine or anti TNF-β (infliximab, Remicade), anti-integrin (namixilab) or who have participated in any other clinical trial within the last 3 months.
- •Subjects with a history of coagulopathy.
- •Women with childbearing potential unless surgically sterile or using adequate contraception (either IUD, oral or Depo-provera contraceptive, or barrier plus spermicide); pregnant or breastfeeding mothers.
- •Subjects, who will be unavailable for the duration of the trial, are unlikely to be compliant with the protocol, or who are felt to be unsuitable by the investigator for any other reason.
- •Subjects who are HIV-positive.
- •Subjects who are HBV-positive
- •Subjects who are HCV-positive.
- •Subjects with active CMV
- •Subjects with anemia (Hb <10.5 gm/dl).
- •Subjects with thrombocytopenia (platelets <100K/µl).
- •Subjects with lymphopenia (absolute lymphocyte count <0.7).
- •Subjects with IgG anti-cardiolipin antibody >16 IU.
- •Prior exposure to anti-CD3 MAb.
- •Known sensitivity to any ingredients in the study drug
- •Any know autoimmune disease except for the studied disorders.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: OKT3 (Drug)
OKT3 - 0.2
Active Comparator
干预措施: OKT3 (Drug)
OKT3 - 1
Active Comparator
干预措施: OKT3 (Drug)
OKT3 - 5
Active Comparator
干预措施: OKT3 (Drug)
结局指标
主要结局
This clinical study is designed to evaluate the safety and the immune-modulatory effects of oral administration of the study drug anti-CD3 MAb to subjects with the metabolic syndrome.
时间窗: 60 days
次要结局
- This clinical study also will include evaluations for markers of efficacy, as described below.(60 days)
研究者
研究点 (1)
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