CTIS2023-510389-28-00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. (STARS extend) - TA799-012
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
- 年龄范围
- 18 至 65+（—）
- 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). Criterion d” is not applicable to sites in France, 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. 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 postmenopausal (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/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. Such methods include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal cont
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
相似试验
进行中（未招募）
1 期
A long-term study to evaluate if KVD900 is safe and effective intreating attacks in patients with Hereditary Angioedema.EUCTR2021-001176-42-BGKalVista Pharmaceuticals Ltd150
进行中（未招募）
1 期
A long-term study to evaluate if KVD900 is safe and effective intreating attacks in patients with Hereditary Angioedema.Hereditary Angioedema Type I or IIMedDRA version: 21.0Level: LLTClassification code 10080956Term: Hereditary angioedema type ISystem Organ Class: 100000004850MedDRA version: 26.0Level: LLTClassification code 10080960Term: Hereditary angioedema type IISystem Organ Class: 100000004850EUCTR2021-001176-42-PLKalVista Pharmaceuticals Ltd150
进行中（未招募）
1 期
A long-term study to evaluate if KVD900 is safe and effective intreating attacks in patients with Hereditary Angioedema.Hereditary Angioedema Type I or IIMedDRA version: 21.0Level: LLTClassification code 10080956Term: Hereditary angioedema type ISystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 26.0Level: LLTClassification code 10080960Term: Hereditary angioedema type IISystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2021-001176-42-ATKalVista Pharmaceuticals Ltd150
进行中（未招募）
1 期
A long-term study to evaluate if KVD900 is safe and effective in treating attacks in patients with Hereditary Angioedema.CTIS2023-505904-41-00Kalvista Pharmaceuticals Limited150
进行中（未招募）
1 期
A long-term study to evaluate if KVD900 is safe and effective intreating attacks in patients with Hereditary Angioedema.Hereditary Angioedema Type I or IIMedDRA version: 21.0Level: LLTClassification code 10080956Term: Hereditary angioedema type ISystem Organ Class: 100000004850MedDRA version: 26.0Level: LLTClassification code 10080960Term: Hereditary angioedema type IISystem Organ Class: 100000004850EUCTR2021-001176-42-NLKalVista Pharmaceuticals Ltd150