PHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQUSING A NOVEL CAPILLARY BLOOD COLLECTION METHOD - Optima
- Conditions
- Children presenting growth failure associated with Growth Hormone Deficiency (GHD), Tuner Syndrome (TS) or Chronic Renal Insufficiency (CRI).NutropinAq™ is given as a daily subcutaneous injection dose:GDH: 0,025- 0,035 mg/kg/day,TS : up to 0,05 mg/kg/day, CRI : up to 0,05 mg/kg/day.No dose adaptation will be allowed during the study period unless tolerance or safety mandates a dose reduction.MedDRA version: 7.0Classification code 10056438
- Registration Number
- EUCTR2004-000356-17-FI
- Lead Sponsor
- Ipsen Scandinavia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
Children (boys and girls under 18) with growth failure associated with:
-inadequate growth hormone secretion
-Turner syndrome, confirmed by karyotype
-chronic renal insufficiency up to renal transplantation
Written informed consent signed by both parents or by the liable parent or by the legal guardian when applicable AND the child when applicable
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
Children with hypersensitivity to somatropin or any of the excipients
Children with closed epiphyses
Children with active neoplasm
Children with acute critical illness due to surgery, multiple accidental trauma
Children with acute respiratory failure
Children having received any unlicensed drug within the previous 30 days
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method