Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy.

• Conditions: Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency; MedDRA version: 12.1Level: LLTClassification code 10056438Term: Growth hormone deficiency

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-04
• 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