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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00256126
Registration number
NCT00256126
Ethics application status
Date submitted
18/11/2005
Date registered
21/11/2005
Date last updated
26/06/2018
Titles & IDs
Public title
Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN®
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Scientific title
A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children Treated With SAIZEN®
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Secondary ID [1]
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24531
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Growth Hormone Deficiency
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Turner Syndrome
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Condition category
Condition code
Metabolic and Endocrine
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Other endocrine disorders
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Renal and Urogenital
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Other renal and urogenital disorders
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Saizen
Treatment: Drugs - Saizen
Experimental: Turner Syndrome (TS) -
Experimental: Growth Hormone Deficiency (GHD) -
Treatment: Drugs: Saizen
Subjects with TS will receive SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month
Treatment: Drugs: Saizen
Subjects with GHD will receive SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) at Month 1
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Assessment method [1]
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IGF-1 SDS was calculated using the Elmlinger reference method. Change in within subject IGF-1 levels (standard deviation scores) at Month 1 from Baseline was assessed. Descriptive statistics were determined for the Baseline and Month 1 assessments, and also for the level of change between these two assessments. If either the Baseline or Month 1 IGF-1 level was missing, then the within-subject change in IGF-1 was assumed to be missing.
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Timepoint [1]
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Baseline, Month 1
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Secondary outcome [1]
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Change From Baseline in Insulin-like Growth Factor Binding Protein - 3 (IGFBP-3) Level at Month 1
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Assessment method [1]
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Timepoint [1]
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Baseline, Month 1
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Secondary outcome [2]
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Change From Baseline in Fasting Glucose Levels at Month 1
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Assessment method [2]
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Timepoint [2]
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Baseline, Month 1
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Secondary outcome [3]
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Change From Baseline in Fasting Insulin Levels at Month 1
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Assessment method [3]
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Timepoint [3]
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Baseline, Month 1
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Secondary outcome [4]
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Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Month 1
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Assessment method [4]
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HOMA-IR is used to assess insulin resistance and calculated by an empirical mathematical formula based on fasting plasma glucose and fasting plasma insulin levels. HOMA-IR = fasting plasma insulin (picomole/liter [pmol/L]) * fasting plasma glucose (millimole/liter [mmol/L]) divided by 22.5.
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Timepoint [4]
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Baseline, Month 1
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Secondary outcome [5]
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Change From Baseline in Bone Alkaline Phosphatase Levels at Month 1
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Assessment method [5]
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Timepoint [5]
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Baseline, Month 1
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Eligibility
Key inclusion criteria
- One of the following diagnoses and candidacy for SAIZEN® therapy:
A) GHD: documented pre-established diagnosis of GHD with a growth hormone (GH) peak
response of <10 microgram per liter (mcg/L) with 2 GH stimulation tests, without priming
with oestradiol.
B) Turner syndrome: documented pre-established diagnosis by karyotype.
- Prepubertal status according to Tanner Pre-established history of normal thyroid
function or adequate substitution for at least 3 months.
- Weight for stature within the population specific normal range (>5th and <95th
percentiles) for gender Willingness and ability to comply with the protocol for the
duration of the study.
- Parent's or guardian's written informed consent, given before any study related
procedure that is not part of the subject's normal medical care, with the
understanding that the subject or parent/guardian may withdraw consent at any time
without prejudice to future medical care. If the child is old enough to read and
write, a separate assent form will be given.
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Minimum age
2
Years
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Maximum age
16
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Acquired GHD due to central nervous system tumour, trauma, infection, infiltration
(documented by imaging), and history of irradiation or cranial surgery
- Previous treatment with GH, growth hormone-releasing hormone (GHRH), anabolic steroids
or any treatment affecting growth.
- Previous treatment with corticosteroids, except in case of topical or inhaled
corticosteroid administration for atopic disease. Corticosteroids for hormonal
substitution are also allowed if the condition and the treatment regimen have been
stable for at least 3 months.
- Severe associated pathology affecting growth such as malnutrition, malabsorption, or
bone dysplasia.
- Chronic severe kidney disease.
- Chronic severe liver disease.
- Chronic infectious disease.
- Acute or severe illness during the previous 6 months.
- Significant concomitant illness that would interfere with participation or assessment
in this study.
- Active malignancy (except non-melanomatous skin malignancies that have undergone
surgical excision and/or biopsy, diagnosis and treatment to resolution)
- History or active Idiopathic intra-cranial hypertension (benign intracranial
hypertension or pseudo-tumor cerebri).
- Diabetes Mellitus type I & II.
- Any autoimmune disease.
- Previous screening failure in this study.
- Use of an investigational drug or participation in another clinical study within the
last three months.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/05/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/09/2007
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Sample size
Target
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Accrual to date
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Final
318
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Local Medical Information Office - Sydney
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Recruitment postcode(s) [1]
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- Sydney
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Buenos Aires
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Country [2]
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Austria
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State/province [2]
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Vienna
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Canada
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State/province [3]
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Mississauga
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Country [4]
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France
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State/province [4]
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Paris
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Country [5]
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Germany
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State/province [5]
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Munich
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Country [6]
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Italy
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State/province [6]
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Rome
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Country [7]
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Norway
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State/province [7]
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Oslo
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Country [8]
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Russian Federation
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State/province [8]
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Russia
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Country [9]
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Singapore
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State/province [9]
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Singapore
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Country [10]
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Spain
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State/province [10]
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Madrid
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Country [11]
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Sweden
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State/province [11]
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Stockholm
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Country [12]
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United Kingdom
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State/province [12]
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Feltham
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Merck KGaA, Darmstadt, Germany
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The study aims at identifying the predictive markers after one month of Saizen therapy in
Growth Hormone Deficiency (GHD) and Turner Syndrome children.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00256126
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Responsible
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Address
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Merck KGaA, Darmstadt, Germany
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00256126
Download to PDF