EUCTR2004-000438-35-DK进行中（未招募）不适用
A study of the Efficacy and Safety of Teduglutide in subjects with Parenteral Nutritional Dependant Short Bowel Syndrome - N/A
PS Allelix Corporation0 个研究点目标入组 125 人开始时间: 2004年8月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 125
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
- •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
排除标准
- •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
- •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.
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