Intestinal failure with an underlying aetiology of short bowel MedDRA version: 20.1 Level: PT Classification code 10049416 Term: Short-bowel syndrome System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Victoza
Product Name: Victoza
Product Code: EU/1/09/529/001-005
Pharmaceutical Form: Solution for injection in pre-filled pen
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: Exclusion criteria • Patients 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 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) o Significant active, uncontrolled diseases e.g. cardiovascular, renal, cancer that would put the subject at undue risk or prevent completion of the study o Major surgical interventions e.g. abdominal, vascular o Cohn’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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Is the GLP-1 agonist liraglutide effective in the reduction in parenteral support requirements for patients with short bowel?;Secondary Objective: Is there an improvement in quality of life of the patients while they are on liraglutide? Is there an change in levels of plasma citrulline (a marker of the small intestinal cell mass) together with gut hormone levels GLP-1, Peptide YY (PYY) and IGF-1? What is the duration of the response of liraglutide? i.e. the proportion of subjects who maintain reduction in weekly PN volume from baseline at week 20. ;Primary end point(s): • Reduction in parenteral nutrition volume at 20 weeks from start of liraglutide ;Timepoint(s) of evaluation of this end point: 20 weeks from start of liraglutide | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in plasma citrulline, GLP-1, IGF-1 and PYY concentrations • Improvement in quality of life score • Duration of response i.e. proportion of subjects who maintain reduction in weekly PN volume from baseline at week 20. . Nights no longer requiring parenteral support;Timepoint(s) of evaluation of this end point: 20 weeks from start of liraglutide | — |
Countries
United Kingdom
Outcome results
None listed