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

• Register: EUCTR
• Last refreshed on: 16 December 2019
• Main ID: EUCTR2010-022215-19-GB
• Date of registration: 23/06/2011
• Prospective Registration: Yes
• Primary sponsor: Greater Glasgow & Clyde NHS
• Public title: Combined growth hormone and IGF1 therapy in paediatric Crohn'd disease
• Scientific title: 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
• Date of first enrolment: 21/07/2011
• Target sample size: 24
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022215-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Control arm with rhGH only
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

United Kingdom

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Impaired growth in Paediatric Crohn's disease
MedDRA version: 14.1 Level: LLT Classification code 10011398 Term: Crohn's System Organ Class: 100000004856

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

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: 67763-96-6
Other descriptive name: Recombinant human Insulin-like Growth Factor
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Trade Name: NutropinAq®
Product Name: NutropinAq 10mg/2ml solution for injection
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Somatropin(rhGH)
CAS Number: 12629-01-5
Other descriptive name: recombinant growth hormone
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-1

Primary Outcome(s)

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

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.

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)

Secondary ID(s)

GHIGF1/2011

Ethics review

Status: Approved
Approval date:
Contact: