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

• Conditions: - growth failure in children caused by decreased or absent secretion of endogenous growth hormone.- growth failure in girls with gonadal dysgenesis (Turner Syndrome), confirmed by chromosomal analysis.; MedDRA version: 7.1Level: PTClassification code 10056438

• Registration Number: EUCTR2004-005054-31-FI
• Lead Sponsor: Serono International S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-31
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 326

Inclusion Criteria

- 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- Parent's or guardian's written informed consent with the understanding that consent may be withdrawn at any time without prejudice to future medical care.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:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- 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;
- Use of investigational drug or participation in another clinical study within the last three months.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified