Special Drug Use Investigation of Revestive Subcutaneous Injection 3.8 mg (All-case Surveillance)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events
研究概览
简要总结
The main aims of this study are to check for side effects from treatment with teduglutide (Revestive) and how well teduglutide controls symptoms of short bowel syndrome.
The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.
During the study, participants with short bowel syndrome will receive an injection of teduglutide just under the skin (subcutaneous) according to their clinic's standard practice. The study doctors will check for side effects from teduglutide for 36 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants in Japan who received teduglutide will be enrolled in this post marketing surveillance.
排除标准
- 未提供
研究组 & 干预措施
Teduglutide 0.05 milligram per kilogram (mg/kg)
Participants will receive Teduglutide 0.05 milligram per kilogram (mg/kg) subcutaneous (SC) injection once daily.
干预措施: Teduglutide (Drug)
结局指标
主要结局
Number of Participants with Adverse Events
时间窗: Up to 36 months
An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Number of Participants with Serious Adverse Events
时间窗: Up to 36 months
A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability /incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
次要结局
- Changes from Baseline in Prescription Volume of Parenteral Nutrition Intravenous (PN/IV) Support(Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation)
- Percentage of Participants who Completely Wean off PN/IV Support(Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation)
- Changes from Baseline in Dose of PN/IV Support(Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation)
- Percent Change from Baseline in Prescription Volume of PN/IV Support(Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation)
- Percent Change from Baseline of Dose in PN/IV Support(Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation)
- Crohn's Disease Activity Index (CDAI)(36 months after teduglutide treatment initiation)