An Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- VectivBio AG
- 入组人数
- 158
- 试验地点
- 66
- 主要终点
- Clinical chemistry
研究概览
简要总结
The primary objective of the trial is to assess long-term safety and tolerability of apraglutide in subjects with SBS-IF.
详细描述
This is an international, multicenter, open label extension trial to collect further safety, tolerability, efficacy, durability, and clinical outcomes of apraglutide once weekly adminstration, for up to 208 weeks or until apraglutide is commercially available in the country, whichever comes first. Eligible subjects would be those who were trial subjects of TA799-007 or TA799-013 trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females with a diagnosis of SBS-IF secondary to surgical resection of the small intestine, with Colon-in-Continuity (CIC) or stoma, who were trial subjects of parent trials TA799-007 or TA799-013
- •Able to give informed consent and agree to follow the details of participation as outlined in the protocol.
排除标准
- •Subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements.
- •Any other reason judged not eligible by the Investigator.
- •Pregnancy or lactation
研究组 & 干预措施
Apraglutide subcutaneous (SC) injections, once weekly
Peptide analogue of Glucagon-like Peptide 2 (GLP-2)
干预措施: Apraglutide (Drug)
结局指标
主要结局
Clinical chemistry
时间窗: From baseline to week 208
Clinical Chemistry panel of analytes will be examined for clinically significant changes.
Adverse events (AE)
时间窗: From baseline to week 208
System organ class, frequency and severity
Hemostasis
时间窗: From baseline to week 104
Hemostasis INR will be examined for clinically significant changes.
Urinalysis
时间窗: From baseline to week 208
Urinanalysis panel of analytes will be examined for clinically significant changes.
Hematology
时间窗: From baseline to week 208
Hematology panel of analytes will be examined for clinically significant changes.
Occurrence of clinically relevant changes in vital signs
时间窗: From baseline to week 208
* Systolic and diastolic blood pressure in mmHg will be examined for clinically significant changes. * Heart rate in Beats per Minute (BPM) will be examined for clinically significant changes.
Occurrence of clinically relevant changes in electrocardiogram
时间窗: From baseline to week 208
ECG; intervals and rhythm
次要结局
- Change from baseline in PS volume(From baseline to week 208)
- Change from baseline in PS frequency(From baseline to week 208)
- Clinically significant changes in PS total energy(From baseline to week 208)
- Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI)(From baseline to week 208)
- Changes from baseline on Patient Global Impression of Satisfaction with Parenteral Support (PGI-SPS)(From baseline to week 208)
- Change from baseline in PS infusion time(From baseline to week 208)
- Percentage of subjects reaching enteral autonomy(From baseline to week 104)
- Change from baseline in body weight(From baseline to week 104)
- Change from baseline on the Patient Global Impression of Severity (PGIS)(From baseline to week 104)
- Change from baseline on the Patient Global Impression of Change (PGIC)(From baseline to week 208)
- Changes from baseline on Patient Global Impression of Treatment Satisfaction (PGI-TS)(From baseline to week 208)
- Changes from baseline on Patient Global Impression of Parenteral Support Impact (PGI-PSI)(From baseline to week 208)
- Change from baseline on the Short Form (36) Health Survey (SF-36)(From baseline to week 208)
- Change from baseline on the EuroQoL-5 dimension -5 level survey (EQ-5D-5L)(From baseline to week 208)