A phase IV open-label study of predictive markers in Growth Hormone Deficient and Turner Syndrome prepubertal children treated with Saizen

Merck Serono International S.A.0 sites326 target enrollmentAugust 12, 2005

Overview

No summary available.

Registry

who.int

Start Date

August 12, 2005

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Merck Serono International S.A.

•\- Children with one of the following diagnoses who are candidate for Saizen therapy:
•A) GHD: documented pre\-established diagnosis of GHD with a GH peak response of \<10 micrograms/L with 2 GH stimulation tests, without priming with oestradiol
•B) Turner syndrome: documented pre\-established diagnosis by karyotype
•\- Prepubertal status according to Tanner (stage 1\)
•\- Pre\-established history of normal tyroid 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 trial
•\- Parent's or guardian's written informed consent with the understanding that consent may be withdrawn at any time without prejudice to future medical care. If the child is old enough to read and write, a separate form will be given
•Are the trial subjects under 18? yes
•Number of subjects for this age range:

•\- Acquired GHD due to central nervous system tumour, trauma, infection, infiltration (documented by imaging), and a history of irradiation or cranial surgery;
•\- Previous treatment with GH, GHRH, anabolic steroids or any treatment affecting growth;
•\- Previous treatment with corticosteroids except topical or inhaled for atopic disease; or when used for hormonal substitution if the condition and treatment regimen has been stable for at least 3 months;
•\- Severe associated pathology affecting growth such as malnutrition, malabsorption or bone dysplasia;
•\- Chronic severe kidney or liver or infectious disease;
•\- Acute or severe illness during the previous 6 months;
•\- 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;
•\- Diabetes Mellitus type I and II
•\- Any autoimmune disease (except chronic auto\-immune thyroiditis with normal levels of thyroid hormones);