NCT00601770已完成2 期
Open-label, Multicenter Trial With IC41, a Therapeutic HCV Vaccine in Patients With Chronic HCV
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 8
- 主要终点
- HCV-RNA 2 weeks after end of treatment
研究概览
简要总结
The objective is to investigate the virological (HCV-RNA) responses following biweekly immunization with IC41.
Treatment phase 14 weeks, total study duration including follow-up period 38 weeks.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained prior to study entry
- •Patients with chronic hepatitis C; genotype 1
- •Treatment naive patients
- •Male and Female, 18 to 55 years
- •Presence of HLA-A2 marker
- •Mentally healthy
- •No clinically relevant pathological findings in any of the investigations at screening
- •Treatment naive patients with chronic Hepatitis C of genotype 1
排除标准
- •Positive results in HIV, HBsAg and HAV-Ag (IgM)
- •Other causes of chronic hepatitis
- •History of autoimmune diseases
- •Previous vaccination with any prophylactic or therapeutic Hepatitis C vaccine (in a clinical study)
- •Active or passive vaccination 4 weeks before and during the entire study period
- •Decompensated liver disease
- •History of severe hypersensitivity reactions and anaphylaxis
- •Known allergic reactions to one of the components of the vaccine and Imiquimod cream
- •Clinically significant diseases which, in the opinion of the Investigator, might lead to frequent hospitalization/medical attendance
- •Malignancies
- •Immunosuppressive therapy
- •Pregnancy, lactation or breast-feeding
- •Unwillingness to practice appropriate contraception
- •Participation in another study with an investigational drug within 1 month prior to enrolment and the entire study period
- •Patients, who in the opinion of the Investigator, might not be able to comply with the study protocol (e.g.: Drug addiction, alcoholism)
研究组 & 干预措施
IC41
Experimental
8 injections of 4 x 0.125mL
干预措施: IC41 (Biological)
结局指标
主要结局
HCV-RNA 2 weeks after end of treatment
时间窗: 2 weeks
次要结局
- Immunological assays and Safety(until study end)
研究者
研究点 (8)
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