EUCTR2011-005678-47-IT进行中（未招募）不适用
A phase II multi-center, randomized, double-blind, controlled vs placebo, long-term extension study to evaluate the safety and tolerability of 40 mg GED-0301for the maintainance of Crohn’s disease in remission. - IGON 2
GIULIANI0 个研究点开始时间: 2011年12月21日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1 Written informed consent, personally signed and dated by the patient prior any study-related procedures is carried out. 2 Patients in remission of Crohn’s disease at the end (Week 12) of the lead-in study.( I.G.O.N. 1 Study - Prot.GED-301-01-11) 3 Female patients not of childbearing potential (women in menopause defined as surgically sterile or one year postmenopausal); female patients of childbearing potential upon negative pregnancy testing at enrollement and using effective method of birth control during the study. 4 Ability to understand and comply with study procedures and restrictions.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1. Pregnant or breast-feeding women. 2. Screening laboratory values within the following parameters: ? APTT > 1.5 ULN ? platelet count =100,000 /mm3 ? serum creatinine>1.5 ULN ? total bilirubin >1.5 ULN (excluding Gilbert Syndrome) ? AST and ALT >1.5 ULN. 3. QTc interval >450 msec for males and >470 msec for females 4. Any medical disorder emerged during/after the participation in IGON 1 that may require treatment (e.g. renal or hepatic impairment) or that make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures
研究者
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