EUCTR2017-004997-32-ES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
Roche Farma, S.A por delegación de Genentech, Inc.0 个研究点目标入组 143 人开始时间: 2018年9月17日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 143
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 judgment
- •-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
- •-Noncompliance 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 within 18 weeks after the final dose of study drug from GA39925, whichever is longer
- •-Any new malignancy, significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders, or signs or symptoms of infection judged by the investigator to be clinically significant since enrolling in the parent study
- •-Use of prohibited therapies as defined in the parent study
- •-Abnormal laboratory value recorded at the last visit in the parent study
研究者
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