Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohnâ??s Disease. - Vedolizumab-4013

Takeda Development Centre Asia Pvt Limited TDC Asia0 个研究点目标入组 0 人待定

概览

阶段: 3 期
干预措施: 未指定
疾病 / 适应症: Health Condition 1: K529- Noninfective gastroenteritis and colitis, unspecified
发起方: Takeda Development Centre Asia Pvt Limited TDC Asia
状态: 进行中（未招募）
最后更新: 4年前

暂无简介。

注册库

who.int

开始日期

待定

结束日期

待定

最后更新

4年前

研究类型

Interventional

发起方

Takeda Development Centre Asia Pvt Limited TDC Asia

•Subjects who have successfully completed participation in qualifying Vedolizumab clinical studies and meet the inclusion/exclusion criteria.
•The number of subjects will be determined based upon the qualifying subjects who have received treatment with Vedolizumab, completed participation in qualifying vedolizumab clinical studies, meet the inclusion/exclusion criteria and agree to enroll in XAP study.
•Received vedolizumab (excluding comparator or placebo subjects) during participation in a qualifying vedolizumab study.
•In the opinion of the investigator, the subject is continuing to derive benefit from vedolizumab and continued treatment with vedolizumab is desired because there is no other comparable product available or the subject may be expected to develop worsening of disease if they were to modify treatment.
•A male subject who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
•A female subject of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.

•For the subjectâ??s particular clinical scenario, vedolizumab is currently available to the subject through commercial channels, including reimbursement.
•Subject has any clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements or poses a risk to the subject being in the study.
•If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 18 weeks after participating in this study; or intending to donate ova during such time period.
•If male, the subject intends to donate sperm during the course of this study or for 18 weeks thereafter. Subject has received a live vaccine in the last 18 weeks or is in need of a live vaccine during the study or up to 18 weeks after the last study dose.

未指定