NCT01061996终止2 期
An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis
Cerimon Pharmaceuticals0 个研究点目标入组 88 人开始时间: 2007年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 88
- 主要终点
- Assess the safety of basiliximab in subjects with ulcerative colitis
研究概览
简要总结
Primary Objective Safety: assess the safety of basiliximab 40 mg, given every 4 weeks, in subjects with ulcerative colitis who completed previous basiliximab studies.
Secondary Objectives: evaluate the efficacy and assess the immunogenicity of this multiple-dose maintenance regimen in this population
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously met eligibility criteria in the previous basiliximab UC study
- •Must have a total Mayo score at entry consistent with clinical response or clinical remission.
- •Signed a current IRB/IEC-approved informed consent form
- •Females of childbearing potential must use an effective birth control method, and be willing to continue birth control during the study, and for 4 months after the last dose of study drug.
- •Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months before study entry, hysterectomy, or bilateral oophorectomy at least 2 months before study entry) or post-menopausal for at least 2 years.
排除标准
- •Subject is severely ill, as evidenced by more than 6 episodes of loose stools, all of them bloody, during a 24-hour period within the prior 7 days, concurrent with any of the following systemic features:
- •Heart rate > 90 beats/min at rest
- •Temperature > 37.8 degrees C
- •Hemoglobin < 10.5 g/dL
- •Subject is currently receiving a restricted/prohibited concomitant medication
- •Subject has undergone colectomy (total, or subtotal)
- •Subject is pregnant or breast-feeding
- •Prior noncompliance with previous study visit schedule and requirements
研究组 & 干预措施
1
Experimental
干预措施: Basiliximab (Drug)
结局指标
主要结局
Assess the safety of basiliximab in subjects with ulcerative colitis
时间窗: 1 year
次要结局
- Evaluate the efficacy and assess the immunogenicity of t his multiple-dose maintenance regimen in this population(1 year)
研究者
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