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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2009-015739-34-DE
Date of registration:	14/09/2009
Prospective Registration:	Yes
Primary sponsor:	Goethe-Universität Frankfurt/Main
Public title:	Status of the growth hormone/ insulin-like growth factor-1 (GH/IGF-1) axis in relation to growth failure, body weight and neuroprotection in children with Ataxia telangiectasia (AT) - Growth hormone in AT (GHAT)
Scientific title:	Status of the growth hormone/ insulin-like growth factor-1 (GH/IGF-1) axis in relation to growth failure, body weight and neuroprotection in children with Ataxia telangiectasia (AT) - Growth hormone in AT (GHAT)
Date of first enrolment:	09/12/2009
Target sample size:
Recruitment status:	Authorised-recruitment may be ongoing or finished
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-015739-34
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
Phase:

Countries of recruitment
Germany

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
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Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
• diagnosis of AT
• no fusion of epiphyses/closed growth plates determined by X-ray of left wrist and hand (special skeletal age film)
• age between 3 years to 18 years and no completed puberty
• growth failure: height below the 10th percentile for chronological age
• growth failure, defined as growth velocity (measured as linear growth) less than 5% to 10% of that expected for children of the same age group, over the past 12 months
•provide evidence of serum IGF-1 level performed within the preceding 6 months and the results fall below normal limits for age

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• fusion of epiphyseal plates
• age under 3 years or completion of puberty
• serum IGF-1 level that is within normal limits for age
• be above the 10th percentile height for chronological age
• history of anaphylactic reaction or hypersensitivity to one of the GH formulation
• any active or suspected neoplasia
• signs of intracranial hypertension as evidenced by papilledema

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

Health Condition(s) or Problem(s) studied

This study will evaluate the status of the growth hormone/ insulin-like growth factor-1 (GH/IGF-1) axis in relation to growth failure, body weight and composition and neuroprotection in children with Ataxia telangiectasia (AT)

Intervention(s)

Trade Name: Catapresan 75, Tabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: Clonidinhydrochlorid
CAS Number: 4205-91-8
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 75-

Trade Name: L-Arginin-hydrochlorid-einmolar Fresenius
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Argininhydrochlorid
CAS Number: 1119-34-2
Concentration unit: g/l gram(s)/litre
Concentration type: equal
Concentration number: 210,7-

Trade Name: Progynova 21 mite
Pharmaceutical Form: Tablet
INN or Proposed INN: Estradiolvalerat
CAS Number: 979-32-8
Concentration unit: mg milligram(s)
Concentration number: 1-

Trade Name: NutropinAq 10mg/2ml (30 I.E.) Injektionsllösung
Pharmaceutical Form: Injection*
INN or Proposed INN: Somatotropin
CAS Number: 12629-01-5
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 30-

Primary Outcome(s)

Primary end point(s): Primary efficacy endpoint: The primary objective is to evaluate the IGF1/GH increase after Arginine provocation test

Secondary Objective: Secondary objective(s):
The GH increase after Clonidine Provocation Test
To evaluate the safety and efficacy of the IgF-1 generation test.
To correlate GH/IGF-1 deficiency to BMI
To correlate GH/IGF-1 deficiency to MRI findings

Main Objective: Primary objective: Primary efficacy endpoint: The primary objective is to evaluate the IGF1/GH increase after Arginine provocation test

Secondary Outcome(s)

Secondary ID(s)

FRA.GHAT.2009

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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