A Pharmacokinetic Study Of The Combined Use Of Recombinant Human GH And IGF-1 In Children With Inflammatory Bowel (Crohn’s) Disease - Combination rhGH + rhIGF-1 in childhood/adolescent Crohn’s

Greater Glasgow & Clyde NHS0 个研究点目标入组 24 人开始时间: 2011年6月23日最近更新: 2019年12月16日

适应症

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•a) diagnosed with Crohn’s disease
•b) exhibit slow growth (HV SDS <-0.5 for chronological age for the previous 6 months)
•c) Age > 6 years and <18 years
•d) be able and willing to participate in the study as evidenced by a parent/legal guardian signing a valid written informed consent and the patient signing to show their assent (if appropriate).
•e) children and parents must be able to understand English either directly or through interpreters.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•a) <6 years old or >18 years of age
•b) abnormal fasting blood sugar or HbA1c
•c) history of dabetesor use of hypoglycaemic agents
•d) history or use of rhGH or IGF-1 therapy within previous 6 months
•e) respiratory failure
•f) major abdominal surgery within the last 3 months
•g) overnight enteral feeding at time of study visits
•h) disorder of liver function
•i) disorder of renal function
•j) any untreated malignancy or tumour
•k) active or suspected neoplasia
•l) documented history of an abnormal or allergic reaction to Increlex
•m) documented history of an abnormal or allergic reaction to Nutopin
•n) acute or critical illness
•o) history of clinically significant organic or psychiatric disease or findings on physical examination, which in the opinion of the Investigator, would prevent the patient from completing the study
•p) abuse of alcohol
•q) abuse of prescription or illicit drugs
•r) pregnancy/or inadequate birth control if female and sexually active

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