A study of the Efficacy and Safety of Teduglutide in subjects with Parenteral Nutritional Dependant Short Bowel Syndrome - N/A
- Conditions
- 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, diarrhea, and dehydration due to the reduced intestinal capacity to absorb macronutrients, water and electrolytes (1-8).
- Registration Number
- EUCTR2004-000438-35-DK
- Lead Sponsor
- PS Allelix Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 125
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.Men and women, aged 18 years of age or older at the time of signing the ICF
3.SBS as a result of major in testinal resection, e.g., due to injury, volvulus, vascular disease, cancer, Crohn’s disease
a.For subjects with a history of cancer (there are exceptions listed in Sec. 4.3 Exclusion criteria), the subject should be disease-free for at least 5 years
b.For subjects with a history of Crohn’s disease, the subject should be in clinical remission, as determined by clinical assessment
4.Body weight must be less than 90 kg at the time of enrollment
5.Major intestinal resection resulting in at least 12 months dependency prior PN to the date of the signature of ICF. Minor ostomy revisions within this time period are allowable
6.At baseline, subjects must require PN treatment to meet their caloric or electrolyte needs due to ongoing malabsorption at least 3 times weekly
7.Stable for at least 4 consecutive weeks just prior to randomization in:
a. Usage and volume of PN
b. 48-hour urinary output (1.0 to 2.0 L/d)
c. Urine sodium (greater than 20 mmol/d)
d. Adequate renal function (serum creatinine and blood urea nitrogen [BUN]1.5 x ULN or less)
e. Hct indicating satisfactory hydration (ULN or less)
f. Motility altering medications (as defined in the Section 5.4)
8.Body mass index (BMI) 18 to 27 kg/m2
9.Adequate hepatic function: (Alanine aminotransferase [ALT] and aspartate aminotransferase [AST] both less than 2. 0 x ULN; total bilirubin less than 1.25 x ULN; and alkaline phosphatase less than 2.5 x ULN)
10.Female subjects who are not surgically sterile or postmenopausal must use 30 days after medically acceptable methods of birth control during and for the treatment period (see Section 6.2.7). Postmenopausal is defined as aged 60 years or older and 2 years must have elapsed since the last menses.
11.Capable of understanding and be willing to adhere to the study visit schedule and other protocol requirements.
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
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.Participation in a clinical study within 30 days prior to signing the ICF, or concurrent participation in any clinical study
4.Clinically significant laboratory abnormalities at the time of randomization
5.Previous use of teduglutide (ALX-0600)
6.Prior use of native GLP-2 within 3 months of screening visit
7.Hospital admission within 1 month prior to screening visit
8.Pregnant or lactating women
9.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
10.Presence of excluded disease. The following is a table of excluded disease states arranged by body systems:
Related to SBS
Radiation enteritis
Scleroderma
Celiac disease
Refractory or tropical sprue
Pseudo-obstruction
Gastrointestinal (GI)
Active inflammatory bowel disease (IBD)
Pre-malignant or malignant change in colonoscopy biopsy or polypectomy
Surgery scheduled within the time frame of the study
Immune
Human immunodeficiency virus (HIV) positive test
Immunological disorders
Possible allergies to teduglutide or its constituents
Cardiovascular, respiratory, renal, endocrine, hepatic, or CNS
Significant active, uncontrolled, untreated systemic diseases
11. Failure to adhere to required washout periods. The following table contains lists of certain medications, arranged by the periods of time that must have transpired after stopping them before the first dose of teduglutide in this study. Use of iv insulin is not excluded.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method