NCT00962936终止1 期
Phase I/II Study to Evaluate the Safety and Tolerability of the Monoclonal Antibody CT-011 in Patients With Chronic Hepatitis C Genotype I Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- CureTech Ltd
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- To assess the safety and tolerability of CT-011 in patients with Chronic Hepatitis C due to HCV Genotype I infection
研究概览
简要总结
This study aims to evaluate whether an investigational monoclonal antibody, CT-011, is safe to give and if it helps patients with hepatitis C virus (HCV). Monoclonal antibodies are a type of drug that is typically given by infusion into a vein (intravenously). Results of this trial will help doctors obtain additional information with regard to the safety and efficacy of CT-011 as a potential treatment for HCV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is between 18 and 60 years of age, both genders.
- •Biopsy proven infection with Hepatitis C genotype
- •Positive for anti-HCV.
- •Chronically infected for at least 3 months from diagnosis.
- •ECOG performance status ≤
- •Previous therapy with interferon +/- Ribavirin or Peginterferon +/- Ribavirin or ineligibility for this type of therapy or for liver transplantation.
排除标准
- •Patients who received any type of anti viral treatment during the 3 months prior to enrollment.
- •Any history or active malignancy.
- •History of major organ transplantation with an existing functional graft.
- •Patients who received any systemic concurrent therapy within the last 4 weeks.
- •Patients progressing to acute liver failure (ALF).
研究组 & 干预措施
CT-011
Experimental
干预措施: CT-011 (Drug)
结局指标
主要结局
To assess the safety and tolerability of CT-011 in patients with Chronic Hepatitis C due to HCV Genotype I infection
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (1)
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