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Trial · Interventional

Status unknownPhase 4Registry data

Status of Growth Hormone/ Insulin-like Growth Factor-1 (GH/IGF-1) Axis and Growth Failure in Ataxia Telangiectasia (AT)

Short name GHAT

NCTNCT01052623 (opens ClinicalTrials.gov in a new tab)Other idFRA.GHAT.2009
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
24 participants (estimated)
Sponsor
Johann Wolfgang Goethe University Hospital · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

Germany

Start
Jan 2010
Primary completion
Dec 2011 (estimated)
Completion
Sept 2012 (estimated)
First posted
20 Jan 2010 (estimated)
Last update posted
5 Jul 2010 (estimated)
Conditions
Ataxia Telangiectasia · Growth Failure

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201120122013
  1. Ph 4

    GHAT

    NCT01052623

    Jan 2010 to est. Sept 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • Somatropin, Clonidine, L-Arginin-Hydrochloride, Estradiol valerateDrug

Arms1

  • Experimental

    Growth hormone-testing (GH/IGF-1-testing)

    Patients (girls over 8 years and boys over 10 years) are primed with estradiol 1 mg orally for 2 days, to help avoid false results of growth hormone (GH) levels in blood samples. Then provocation testing is done, with two tests back to back. It determines blood levels of GH and the body's response to testing with drugs called arginine and clonidine. Patients are admitted to the pediatric inpatient unit and will have an intravenous (IV) line placed in the arm. Arginine is given by IV over 30 minutes, and blood samples are taken as indicated. The next day, the clonidine test is performed according to current guidelines. Then the IGF-1 generation test is done to see if the patient has the ability to generate IGF-1 in response to injections of GH for 5 consecutive days.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. To evaluate the GH increase after Arginine Provocation Test

    Time frame · at minute 0, 30, 60, 90 und 120 after infusion

Secondary outcomes(1)

  1. 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

    Time frame · at minute 0, 30, 60, 90 und 120 after dosing of Clonidin. IgF-1 generation test after 5 days.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 3 Years up to 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Have a diagnosis of AT * Have no fusion of epiphyses/closed growth plates as determined by X-ray of left wrist and hand (special skeletal age film) * Be between 3 years to 18 years old and have not completed puberty * Consent to permit blood and/or tissue samples for storage * Demonstrate growth failure: height below the 10th percentile for chronological age * Have a primary care physician at home * Demonstrate growth failure, defined as growth velocity (measured as linear growth) that is less than 5% to 10% of that expected for children of the same age group, over the past 12 months * Willingness to remain hospitalized for several days * Provide evidence of serum IGF-1 level performed within the preceding 6 months and the results fall below 25% range of normal limits for age Exclusion Criteria: * Have fusion of epiphyseal plates * Be under the age of 3 years or have reached completion of puberty * Have a serum IGF-1 level that is above the 25% range of normal limits for age * Be above the 10th percentile height for chronological age * Demonstrate any history of anaphylactic reaction or hypersensitivity to one of the GH formulation * Have any active or suspected neoplasia * Demonstrate signs of intracranial hypertension as evidenced by papilledema upon examination by fundoscopy * Have any condition that, in the investigator's opinion, places the patient at undue risk by participating in the study * Be unwilling to undergo testing or procedures associated with this protocol * Have acute or chronic infections * Have a hypersensitivity to one of the drugs: Clonidine hydrochlorid, Arginine hydrochlorid, Estradiol valerate, Somatropin * Have a presence of bradycardia, cardiac arrhythmia, have symptoms of a sick sinus syndrome * Suffer from depression * Have acute or recurrent thrombosis * Have acute liver diseases

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