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Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN®

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ClinicalTrials.gov Identifier: NCT00256126
Recruitment Status : Completed
First Posted : November 21, 2005
Results First Posted : March 20, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Merck KGaA

November 18, 2005
November 21, 2005
August 24, 2017
March 20, 2018
March 20, 2018
May 31, 2005
September 30, 2007   (Final data collection date for primary outcome measure)
Change From Baseline in Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) at Month 1 [ Time Frame: Baseline, Month 1 ]
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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Complete list of historical versions of study NCT00256126 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Insulin-like Growth Factor Binding Protein - 3 (IGFBP-3) Level at Month 1 [ Time Frame: Baseline, Month 1 ]
  • Change From Baseline in Fasting Glucose Levels at Month 1 [ Time Frame: Baseline, Month 1 ]
  • Change From Baseline in Fasting Insulin Levels at Month 1 [ Time Frame: Baseline, Month 1 ]
  • Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Month 1 [ Time Frame: Baseline, Month 1 ]
    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.
  • Change From Baseline in Bone Alkaline Phosphatase Levels at Month 1 [ Time Frame: Baseline, Month 1 ]
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Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN®
A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children Treated With SAIZEN®
The study aims at identifying the predictive markers after one month of Saizen therapy in Growth Hormone Deficiency (GHD) and Turner Syndrome children.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Growth Hormone Deficiency
  • Turner Syndrome
  • Drug: 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
  • Drug: 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.
  • Experimental: Turner Syndrome (TS)
    Intervention: Drug: Saizen
  • Experimental: Growth Hormone Deficiency (GHD)
    Intervention: Drug: Saizen

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
318
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September 30, 2007
September 30, 2007   (Final data collection date for primary outcome measure)

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.

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.
Sexes Eligible for Study: All
2 Years to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Austria,   Canada,   France,   Germany,   Italy,   Norway,   Russian Federation,   Singapore,   Spain,   Sweden,   United Kingdom
 
 
NCT00256126
24531
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Merck KGaA
Merck KGaA
Not Provided
Study Director: Medical Responsible Merck KGaA
Merck KGaA
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP