Teduglutide for Treatment of Enterocutaneous Fistula (ECF) - a Pilot Study to Demonstrate Safety and Feasibility
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in Average 3-day Fistula Percent Volume
研究概览
简要总结
The purpose of this study is to determine whether Teduglutide is safe and feasible to be given for the treatment of enterocutaneous fistula (ECF). The hypothesis is that the drug will be well tolerated and will improve the volume of daily ECF output as well as improve the functional quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Enterocutaneous fistula (ECF) that could be secondary to volvulus, injury, prior trauma or surgery, or vascular ischemia
排除标准
- •Perianal fistula
- •Clinical suspicion of inflammatory bowel disease
- •History of radiation enteritis or sprue (as defined by history)
- •Active (<1 year) alcohol or drug abuse
- •Significant hepatic, or cardiac diseases as defined as:
- •Hepatic: aspartate aminotransferase (AST) > 2 times upper limit of normal (10-40 U/L)
- •Cardiac: unstable angina or evidence of active myocardial ischemia (elevated troponin level drawn by clinical suspicion)
- •Severe renal dysfunction: serum creatinine > 2 times upper limit of normal (0.6-1.5 mg/dL)
- •Received glutamine less than 4 weeks prior to screening
- •Receiving growth factors (erythropoietin, granulocyte colony-stimulating factor, granulo-cyte-macrophage colony stimulating factor, and human growth hormone)
- •Pregnancy or lactation (women of childbearing age will be excluded if they do not agree to either complete sexual abstinence during the study or if they refuse to use at least two forms of highly effective contraception such as oral contraception, injectable or implantable contraception, vaginal rings, or intrauterine devices (IUD))
- •Active malignancy or suspicion for gastrointestinal malignancy on CT scan
- •Not capable of understanding or not willing to adhere to the study visit schedule and drug administration requirements
- •Family history of intestinal malignancy (gastric, small intestine, colon)
- •Personal or family history of hereditary non-polyposis colorectal cancer, familial adenomatous polyposis, first degree relative with colon cancer
- •Positive hemoccult (per rectum)
- •Abnormal baseline electrocardiogram (ECF) suggestive of congestive heart failure or underlying cardiac disease
- •Taking oral benzodiazepines, barbiturates, or phenothiazines
研究组 & 干预措施
Standard of Care followed by Teduglutide
Participants in this group will receive standard of care treatment for the first 8 weeks followed by daily Teduglutide for the next 8 weeks.
Subjects with a favorable response will be offered an open label extension during which they will continue to receive teduglutide for up to another 12 months or permanent fistula closure.
干预措施: Teduglutide (Drug)
Standard of Care followed by Teduglutide
Participants in this group will receive standard of care treatment for the first 8 weeks followed by daily Teduglutide for the next 8 weeks.
Subjects with a favorable response will be offered an open label extension during which they will continue to receive teduglutide for up to another 12 months or permanent fistula closure.
干预措施: Standard of Care (Other)
Teduglutide followed by Standard of Care
Participants in this group will receive daily Teduglutide treatment for the first 8 weeks followed by standard of care for the next 8 weeks.
Subjects with a favorable response will be offered an open label extension during which they will continue to receive teduglutide for up to another 12 months or permanent fistula closure
干预措施: Teduglutide (Drug)
Teduglutide followed by Standard of Care
Participants in this group will receive daily Teduglutide treatment for the first 8 weeks followed by standard of care for the next 8 weeks.
Subjects with a favorable response will be offered an open label extension during which they will continue to receive teduglutide for up to another 12 months or permanent fistula closure
干预措施: Standard of Care (Other)
结局指标
主要结局
Change in Average 3-day Fistula Percent Volume
时间窗: Baseline, Up to 8 weeks
Percent fistula volume will be reported from the participant
次要结局
- Quality of Life as Measured by the PROMIS Scale v1.2 - Global Health(Up to 16 weeks)
- Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Belly Pain 5a(Up to 16 weeks)
- Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Diarrhea 6a(Up to 16 weeks)
- Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Nausea and Vomiting 4a(Up to 16 weeks)
- Quality of Life as Measured by the PROMIS Scale v2.0 - Ability to Participate in Social Roles and Activities - Short Form 8a(Up to 16 weeks)
- Number of Participants With Ceased Fistula Output(Up to 16 weeks)
- Quality of Life as Measured by ASCQ-Me® v2.0 Social Functioning - Short Form(Up to 16 weeks)
- Quality of Life as Measured by the ASCQ-Me® v2.0 Sleep Impact - Short Form(Up to 16 weeks)
研究者
Daniel Dante Yeh
Associate Professor of Surgery
University of Miami