EUCTR2017-004997-32-IT进行中（未招募）1 期
A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE - NA
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 320
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
- •- Prior enrollment in Study GA29469 or Study GA39925 and meeting
- •protocol defined entry criteria
- •- Ability to comply with requirements of the study, in the investigator's
- •- Age 18-80 years
- •- For women and men: Use of highly effective contraception as defined
- •by the protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 272
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 48
排除标准
- •Withdrawal of consent from parent study
- •Discontinuation of study drug as required by the parent study protocol
- •Discontinuation of study drug and withdrawal from Study GA29469 prior to Day 85 or from Study GA39925 prior to Week 8
- •Non compliance in the parent study, specifically defined as missing scheduled visits or non adherence with background medications and concomitant medications
- •Pregnant or breastfeeding, or intending to become pregnant during the study or within 8 weeks after the final dose of study drug or 18 weeks after final dose of study drug from Study GA39925 (due to the possibility of receiving vedolizumab), whichever is longer
- •Any new malignancy since enrolling in the parent study
- •Any new significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or GI disorders, since enrolling in the parent study
- •Any new signs or symptoms of infection judged by the investigator to be clinically significant since enrolling in the parent study
研究者
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