Short Bowel Syndrome (SBS) refers to the clinical situation whereby a significant reduction in the absorptive capacity of the intestine results from inadequate anatomical or functional length of residual small intestine following surgical resection. These patients are highly prone to malnutrition, diarrhoea, and dehydration due to the reduced intestinal capacity to absorb macronutrients, water and electrolytes.
Conditions
Interventions
Product Name: Teduglutide (5mg/0.5ml)
Product Code: ALX-0600
Pharmaceutical Form: Powder and solvent for solution for injection
Current Sponsor code: ALX-0600
Other descriptive name: Recombinant glyci
Sponsors
NPS Allelix Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria can be enrolled in this study: 1. Signed and dated informed consent form (ICF) before any study-related procedures are performed 2. Completion of protocol CL0600-004 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded: 1. History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state. This does not include resected cutaneous basal or squamous cell carcinoma, or in situ cervical cancer 2. History of alcohol or drug abuse (within previous year) 3. Prior use of native GLP-2 within 3 months of screening visit 4. Pregnant or lactating women 5. Any condition or circumstance, which in the investigator’s opinion would put the subject at any undue risk, prevent completion of the study, or interfere with analysis of the study results 6. Failure to adhere to required washout periods
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to evaluate the long-term safety and efficacy of daily sc (subcutaneous) administration of teduglutide in subjects with PN (Parenteral Nutrition)-dependent SBS. The primary objective is to evaluate the long-term safety and tolerability of daily teduglutide dosing for up to 12 months in adult subjects with SBS dependent on PN.;Secondary Objective: The secondary objective of the study is to evaluate the long-term effects of teduglutide dosing on reductions in PN for those subjects who received teduglutide or placebo in protocol CL0600-004.;Primary end point(s): Reduction in PN volume forms the basis for most of the efficacy evaluations. Plasma citrulline levels will be measured in all subjects to assess absorptive enterocyte mass. Quality of life will also be evaluated. | — |
Countries
Denmark
Outcome results
None listed