NL-OMON46443撤回2 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 - GA40209
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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
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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