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Predictive Markers in GHD and TS Children Treated With SAIZEN®

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ClinicalTrials.gov Identifier: NCT00256126
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : March 27, 2014
Information provided by:
Merck KGaA

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. The study will recruit approximately 360 children in several countries worldwide. The study lasts for about the first one month of daily growth hormone treatment. There will be three clinic visits during the month of the study. There is an initial visit, then a visit before growth hormone treatment starts and finally a visit at the fourth week of treatment. The study requires two additional blood tests to a regular Saizen treatment follow-up. One sample is taken before growth hormone injections start and one additional blood sample is taken at the fourth week of treatment.

Condition or disease Intervention/treatment Phase
Growth Hormone Deficiency Drug: Saizen Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 318 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children Treated With SAIZEN®
Study Start Date : May 2005
Primary Completion Date : October 2007
Study Completion Date : October 2007

Arm Intervention/treatment
Experimental: 1 Drug: Saizen
blood sampling (10 ml) at baseline and one month (10 ml)

Primary Outcome Measures :
  1. Changes in serum IGF-1 levels after one month in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) children [ Time Frame: After one month ]

Secondary Outcome Measures :
  1. The changes of IGBP-3 levels [ Time Frame: After one month ]
  2. The changes of glycemia and insulinemia, insulin resistance (HOMA-IR analysis) [ Time Frame: After one month ]
  3. The changes of alkaline phosphatase [ Time Frame: After one month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • One of the following diagnoses and candidacy for SAIZEN® therapy:

A)GHD: documented pre-established diagnosis of GHD with a GH peak response of <10 μg/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, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00256126

Local Medical Information Office
Buenos Aires, Argentina
Local Medical Information Office
Sydney, Australia
Local Medical Information Office
Vienna, Austria
Local Medical Information Office
Mississauga, Canada
Local Medical InformationOffice
Paris, France
Local Medical Information Office
Munich, Germany
Local Medical Information Office
Rome, Italy
Local Medical Information Office
Oslo, Norway
Russian Federation
Local Medical Information Office
Russia, Russian Federation
Local Medical Information Office
Singapore, Singapore
Local Medical Information Office
Madrid, Spain
Local Medical Information Office
Stockholm, Sweden
United Kingdom
Local Medical Information Office
Feltham, United Kingdom
Sponsors and Collaborators
Merck KGaA
Study Chair: Clement Olivier Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clement Olivier, Merck Serono International SA, an affiliate of Merck KGaA Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT00256126     History of Changes
Other Study ID Numbers: 24531
First Posted: November 21, 2005    Key Record Dates
Last Update Posted: March 27, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Dwarfism, Pituitary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases