EUCTR2020-005194-27-DK进行中（未招募）1 期
A Single-Center Phase 3b Trial Investigating the Long-term Effect on IntestinalAbsorption, Nutritional Status and Long-Term Safety of treatment with Glepaglutide in Patientswith Short Bowel Syndrome (SBS) - EASE SBS 4
Zealand Pharma A/S0 个研究点目标入组 16 人开始时间: 2021年1月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Informed consent obtained before any trial-related activities. Trial-related activities are any
- •procedures that are carried out as part of the trial, including activities to determine suitability
- •for the trial.
- •2. Age = 18 years and = 90 years at screening.
- •3. Willing to comply with trial procedures, including 2 in-house visits with urine and fecal
- •output collection.
- •4. Stable condition of SBS either with intestinal failure (IF) or intestinal insufficiency. For
- •patients with SBS-IF a stable condition is defined as < 25% change in PS volume or energy
- •content for 4 weeks prior to screening.
- •5. Stable body weight (<5% change in weight in the 3 months prior to screening).
- •6. Wet weight of fecal excretion =1,500 g/day demonstrated during a hospital stay prior to
- •screening*.
- •*If inclusion criteria #6 cannot be met, a visit may be scheduled where fecal output collected at
- •home by the patient or during a hospital stay can be assessed. If the wet weight of fecal excretion
- •=1,500 g/day can be demonstrated, the criterion #6 is met.
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1. Current, or within 30 days prior to screening, participation in another interventional clinical
- •trial that includes administration of an active compound.
- •2. Mental incapacity or language barriers which preclude adequate understanding or
- •cooperation, or unwillingness to comply with trial requirements.
- •3. Previous participation in this trial. Participation is defined as having received trial product.
- •4. Females of childbearing potential, who are pregnant, breast-feeding, intend to become
- •pregnant or are not using highly effective contraceptive methods. Male patients with female
- •partners, who intend to become pregnant.
- •Medical history and concomitant diseases
- •5. More than 2 SBS-related or PS-related hospitalizations (e.g., catheter-related
- •bacteremia/sepsis, bowel obstruction, severe water-electrolytes disturbances, etc.) within
- •6 months prior to screening.
- •6. Poorly controlled inflammatory bowel disease (IBD) that is moderately or severely active or
- •fistula interfering with measurements or examinations required in the trial.
- •7. Current bowel obstruction.
- •8. Known radiation enteritis or significant villous atrophy, e.g., due to active celiac disease.
- •9. Cardiac disease defined as: decompensated heart failure (New York Heart Association
- •[NYHA] Class III-IV), unstable angina pectoris, and/or myocardial infarction within the last
- •6 months prior to screening.
- •10. Clinically significant abnormal electrocardiogram (ECG) as judged by the Investigator.
- •11. Human immunodeficiency virus (HIV) positive, acute liver disease including positive results
- •for Hepatitis B antigens (HBsAg) and Hepatitis C (HCV), or unstable chronic liver disease.
- •12. Any history of colon cancer. History of any other cancers (except margin-free resected
- •cutaneous basal or squamous cell carcinoma or adequately treated in situ cervical cancer)
- •unless disease-free state for at least 5 years.
- •13. Hepatic impairment defined as:
- •a. Total bilirubin = 2 × the upper limit of normal (ULN), or
- •b. Aspartate aminotransferase (AST) = 5 × ULN, or
- •c. Alanine aminotransferase (ALT) = 5× ULN
- •14. Use of GLP-1, GLP-2, human growth hormone (HGH), somatostatin, or analogs thereof,
- •within 3 months prior to screening.
- •15. Known or suspected hypersensitivity to glepaglutide, its components or related products.
- •16. Use of dipeptidyl peptidase (DPP)-4 inhibitors within 3 months prior to screening.
- •17. Surgical resection of gut tissue within 6 months prior to screening.
- •18. Systemic immunosuppressive therapy for treatment of the gastrointestinal tract that has been
- •introduced or has been unstable within 3 months prior to screening.
- •19. Unstable biological therapy (e.g. anti-TNF-a, natalizumab, etc.) within 6 months prior to
- •screening, including significant changes in doses or switch of drug.
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