JPRN-jRCT2031220255招募中3 期
An open-label extension trial to evaluate the long-term safety of apraglutide in short bowel syndrome
Akinori Kashiyama0 个研究点目标入组 12 人开始时间: 2022年8月8日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
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
- >= 18age old 至 ot applicable（—）
- 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 have completed parent trials TA799-007 or TA799-013 and
- •a. Did not meet any stopping criteria
- •b. 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. Complete the last two scheduled visits of the parent trial. Subjects who were forced to withdraw from TA799-007 for logistical reasons not related to the efficacy or safety of apraglutide (e.g., hospitalization for a car accident, COVID-19 pandemic, or emergency surgery) which resulted in several consecutive missed doses may be eligible to participate in this trial upon approval by the Medical Monitor
- •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 visit. Such methods include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner. To be considered sterilized or infertile, females must have undergone surgical sterilization (bilateral tubectomy, hysterectomy or bilateral ovariectomy) or be post-menopausal (defined as at least 12 months amenorrhea without an alternative medical cause, may be confirmed with follicle-stimulating hormone [FSH] test in case of doubt). Women who do not engage in heterosexual intercourse will be allowed to join the trial without contraception following a thorough discussion with the Investigator to determine if this is feasible for the subject. The following methods are not considered acceptable methods of contraception: calendar, ovulation, symptothermal, post-ovulation methods, withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method
- •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 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 visit. Such methods include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device; intrauterine hormone-releasing system, bilateral tubal occlusion
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. Any other reason judged not eligible by the Investigator
研究者
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