Tratamiento combinado con factor de crecimiento insulínico tipo I recombinante (rhIGFI) y hormona de crecimiento (rhGH) en niños prepuberales con déficit idiopático de hormona de crecimiento y mala respuesta al primer año de tratamiento con hormona de crecimiento. Ensayo Clínico de fase II, prospectivo, aleatorizado, abierto, multicéntrico de grupos paralelos en los que se compara dosis fija de rhGH mas dosis flexibles de rhIGFI versus dosis fija de rhGH - No aplica

• Conditions: iños pre-puberales con déficit idiopático de hormona de crecimiento; MedDRA version: 12.1Level: LLTClassification code 10056438Term: Growth hormone deficiency

• Registration Number: EUCTR2010-020742-10-ES
• Lead Sponsor: Ipsen Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

? Treatment with rhGH at a minimum starting dose of 0.025 mg/kg/day (without dose reduction) to a maximum dose of 0.035 mg/kg/day for at least 12 months and a maximum of 18 months based on the diagnosis of IGHD with a pre-treatment GH stimulation test/spontaneous maximum of GH < 10µg/L
? First year of rhGH treatment resulting in height gain < 0.5 SDS
? Chronological age from 3 to 9 years inclusive for girls, from 3 to 10 years inclusive for boys
? Pre-pubertal: Tanner stage 1 (Girls: Tanner B1, Boys: Testis ? 3ml)
? Parent(s)/guardian(s) have provided written informed consent
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

? Evidence (more than 20% rhGH injections missed) or suspicion of poor compliance during the first year of rhGH treatment
? Hypothalamic-pituitary tumours diagnosed or treated prior to screening
? Evidence of any active malignancy or intracranial tumours
? Co-morbidity known to affect linear growth including, but not limited to, skeletal dysplasia
? Chronic illness including but not limited to diabetes, inborn errors of metabolism, osteochondrodystrophy, disorders of genitourinary, cardiopulmonary, gastrointestinal, or central nervous system
? Any named syndrome known to be associated with short stature but not limited to Prader-Willi syndrome, Russel Silver syndrome, etc.
? Neurological disease and mental disabilities that may interfere with compliance [Attention Deficit Hyperactivity Disorders (ADHD), autism, Asperger]
? Ongoing drug treatment known to alter growth, including but not limited to high dose glucocorticoids
? Multiple hormonal deficiencies except hypothyroidism if corrected and well controlled
? Abnormal findings at previous fundoscopy or echocardiogram
? Significant abnormality in clinical screening laboratories, as determined by the Investigator
? Syndromes that predispose the subject to cancer (e.g. Fanconi syndrome, Bloom syndrome, ataxia telangectasia)
? Active seizure disorders, defined as one or more seizures per month irrespective of anticonvulsant therapy
? Known allergy or hypersensitivity to any components of NutropinAq® (somatropin) or Increlex® (mecasermin)
? Acute critical illness due to complications following open heart or abdominal surgery, multiple accidental traumas or acute respiratory failure
? Any current or previous exposure to therapeutic spinal irradiation
? Prior bone marrow transplantation
? Evidence of clinical malnutrition or growth deficit attributable to emotional deprivation
? Participation in a clinical trial within the last 12 weeks
? Any social or medical condition that, in the opinion of the Investigator, would be detrimental to either the subject or the study

Study & Design

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