EUCTR2020-005513-41-DK进行中（未招募）1 期
An open-label extension trial to evaluate the long-term safety of apraglutide in short bowel syndrome
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- VectivBio AG
- 入组人数
- 154
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
- 性别
- All
入选标准
- •1. Males and females with a diagnosis of SBS-IF secondary to surgical resection of the small intestine, with CIC or stoma who were trial subjects of TA799-007 or TA799-013 (parent trials) and:
- •a. Did not meet any stopping criteria.
- •b. For those subjects who completed a parent trial, they have received a minimum of 70% of the planned doses in the trial (unless an AE precluded the subject from meeting this percentage; in this case, the Investigator will decide if the subject will benefit from enrolling in the trial).
- •c. For those subjects who completed a parent trial, they have completed the last two scheduled visits of the parent trial. Subjects who were forced to withdraw from TA799-007 or TA799-013 for logistical reasons not related to the efficacy or safety of apraglutide (e.g., hospitalization for a car accident, coronavirus disease (COVID-19) pandemic, emergency surgery, etc.) which resulted in several consecutive missed doses, including the last 2 visits, may be eligible to participate in this trial upon approval by the Medical Monitor.
- •d. When the required number of trial-completed subjects is achieved in a parent trial, the remaining subjects still on treatment may prematurely discontinue the parent trial and roll over into TA799-012 (before completing all the parent trial visits)
- •2. Able to give informed consent and agree to follow the details of participation as outlined in this protocol.
- •3. Women of childbearing potential must agree to use a highly effective method of contraception during the trial and for 4 weeks after the EOT/early termination/safety follow-up visit.
- •4. Male subjects with a female partner of childbearing potential must commit to practice methods of contraception and abstain from sperm donation during the trial and for 2 weeks after the EOT/early termination/safety follow-up visit. Nevertheless, if their partners are women of childbearing potential, they must agree to practice contraception and use a highly effective method of contraception during the trial and for 4 weeks after the EOT/early termination/safety follow-up visit.
- •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 84
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •1. Subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements.
- •2. Subject not undergoing a baseline colonoscopy (if anatomically feasible) or colonography and not having had all identified colonic or rectal polyps removed
- •3. Judged not eligible by the Investigator for any other reason.
研究者
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