Combined growth hormone and IGF1 therapy in paediatric Crohn'd disease

Phase 1

• Conditions: MedDRA version: 14.1Level: LLTClassification code 10011398Term: Crohn'sSystem Organ Class: 100000004856; Impaired growth in Paediatric Crohn's disease; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2010-022215-19-GB
• Lead Sponsor: Greater Glasgow & Clyde NHS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-23
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified