EUCTR2016-004797-18-GB进行中（未招募）1 期
Pilot study of the GLP-1 agonist, Liraglutide, on decreasing parenteral support requirements in short bowel patients. - SLiPS study (Study of LIragultide on decreasing Parenteral Support)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 5
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
- •Inclusion criteria
- •1.Short bowel with jejunostomy (=200cm) as a result of major intestinal resection (e.g. due to injury, volvulus, vascular disease, Crohn’s disease).
- •2.12 continuous months of parenteral support (PS) dependency prior to enrolment.
- •3.PS required at least 3 times per week to meet their caloric, fluid or electrolyte needs due to on-going malabsorption.
- •4.Stable PS for at least 4 consecutive weeks immediately prior to randomisation. Stability is described as:
- •a.Actual PS usage should match prescribed PS;
- •b.Baseline 48-hour urine output is 1-2 L/24 hours.
- •5.Body mass index = 19.5 kg/m2.
- •6.Adequate hepatic and renal function:
- •a.Total bilirubin within the normal range;
- •b.Alanine aminotransferase (ALT) = 2.5x upper limit of normal;
- •c.Serum creatinine =1.5x upper limit of normal.
- •7.Stable dosage for > 4 weeks, prior to baseline evaluations, of anti-motility and anti-diarrhoeal agents, H2 antagonists, proton pump inhibitors, bile sequestering agents and oral rehydration solutions.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Exclusion criteria
- •Patients < 18 years of age
- •Pregnancy (Female subjects who are not surgically sterile or post menopausal (defined as aged 55 years or older and/or at least 2 years have elapsed since the last menses) or who are not using medically acceptable methods of birth control during and for 30 days after the treatment period)
- •Active malignancy
- •Previous malignancy within the past 5 years
- •History of multiple endocrine neoplasia type 2 (MEN 2)
- •Personal history or family history of medullary thyroid cancer
- •Raised Serum Calcitonin (a biomarker for medullar thyroid cancer) at beginning of trial period
- •Concurrent use of octeotride
- •History of cardiac failure
- •Concurrent use of diuretics
- •Previous history of pancreatitis
- •Recent use of other incretin based therapy in the previous 3 months
- •Type 1 or Type 2 diabetes
- •Alcohol or drug abuse in last year
- •> 4 hospitalisations related to short bowel or its treatment over the previous year
- •Any hospitalisation 30 days prior to screening
- •Introduction or dose adjustment of immunosuppressant for inflammatory bowel disease within 3 months, or treatment with biologics within the past 6 months (systemic corticosteroids, methotrexate, cyclosporine, tacrolimus, sirolimus, MMF, infliximab, adalimumab, vedolizumab)
- •BMI < 19 kg/m2 or > 27kg/m2 (An upper cut-off BMI of > 27kg/m2 has been chosen, as in these patients, there is often a desire to reduce BMI which will conflict with the study design by adding another variable)
- •Scleroderma/radiation enteritis/coeliacs disease/refractory or tropical sprue
- •Liver and renal function outside the inclusion range
- •2.3.4 Subject withdrawal criteria
- •Participants may withdraw at any point in time during the trial and for any reason. If a patient withdraws, the reason for withdrawal will be documented.
- •If a participant has weight loss during the study such that the BMI drops below 19 kg/m2 or there is a 10% reduction in weight between clinic appointments the patient will be withdrawn.
- •If a participant becomes pregnant during the study they will be withdrawn.
- •Development of any of the following criteria that would interfere with the analysis of study results (i.e. compromise PN)
- •oSignificant active, uncontrolled diseases e.g. cardiovascular, renal, cancer that would put the subject at undue risk or prevent completion of the study
- •oMajor surgical interventions e.g. abdominal, vascular
- •oCohn’s disease flare up
- •Occurrence of a serious adverse event (SAE) thought to be study drug related
- •Death of a patient
- •Investigator decision (i.e. subject non compliance with study procedures)
- •Significant adverse event (AE) or medical decision that precludes the subject from adhering to study requirements
- •Discontinued subjects will not be replaced.
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