Impaired growth in Paediatric Crohn's disease MedDRA version: 14.1 Level: LLT Classification code 10011398 Term: Crohn's System Organ Class: 100000004856
Conditions
Interventions
Trade Name: Increlex
Product Name: Increlex 10mg/ml solution for injection
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Mecasermin [rDNA Origin] 10mg/ml solution
CAS Number: 67763
Sponsors
Greater Glasgow & Clyde NHS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) diagnosed with Crohn’s disease b) exhibit slow growth (HV SDS 6 years and =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: a) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to perform a short-term study to assess how well tolerated combined recombinant growth hormone therapy (rhGH) and insulin-like growth factor (rhIGF-1) therapy is compared to rhGh alone in children/adolescents with Crohn's disease. i.e. will it be acceptable to a child to give two injections in the morning? It is hoped that the results from this phase II study will provide the scientific and safety data to allow us to apply for regulatory permission to move on to a Phase III study of long term growth in children/adolescents whose growth is affected by their inflammatory bowel disease.;Secondary Objective: 1) To monitor the effects of combination therapy on short-term markers of the GH/IGF-1 axis (i.e. examine growth factors in the blood). 2) To monitor the effects on biochemical markers of GH/IGF1 action on glucose homeostasis ;Primary end point(s): Safety and tolerability of dual IMP administration compared to individual IMP;Timepoint(s) of evaluation of this end point: Visit 1 - day 1 to visit 1 day 3 Visit 2 - day 1 to visit 2 day 3 Visit 3 - day 1 to visit 3 day 3 (+ 30 days for post IMP adverse event reporting) | — |
Countries
United Kingdom
Outcome results
None listed