Predictive Markers in GHD and TS Children Treated With SAIZEN®

This study has been completed.
Sponsor:
Information provided by:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00256126
First received: November 18, 2005
Last updated: March 26, 2014
Last verified: March 2014

November 18, 2005
March 26, 2014
May 2005
October 2007   (final data collection date for primary outcome measure)
Changes in serum IGF-1 levels after one month in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) children [ Time Frame: After one month ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00256126 on ClinicalTrials.gov Archive Site
  • The changes of IGBP-3 levels [ Time Frame: After one month ] [ Designated as safety issue: No ]
  • The changes of glycemia and insulinemia, insulin resistance (HOMA-IR analysis) [ Time Frame: After one month ] [ Designated as safety issue: No ]
  • The changes of alkaline phosphatase [ Time Frame: After one month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Predictive Markers in GHD and 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. 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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Growth Hormone Deficiency
Drug: Saizen
blood sampling (10 ml) at baseline and one month (10 ml)
Experimental: 1
Intervention: Drug: Saizen
Stevens A, Clayton P, Tatò L, Yoo HW, Rodriguez-Arnao MD, Skorodok J, Ambler GR, Zignani M, Zieschang J, Della Corte G, Destenaves B, Champigneulle A, Raelson J, Chatelain P. Pharmacogenomics of insulin-like growth factor-I generation during GH treatment in children with GH deficiency or Turner syndrome. Pharmacogenomics J. 2014 Feb;14(1):54-62. doi: 10.1038/tpj.2013.14. Epub 2013 Apr 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
318
October 2007
October 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 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.
Both
2 Years to 16 Years
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
Not Provided
Clement Olivier, Merck Serono International SA, an affiliate of Merck KGaA Darmstadt, Germany
Merck KGaA
Not Provided
Study Chair: Clement Olivier Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany
Merck KGaA
March 2014

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