At a glance
ClinicalIndex Comparison Record- ✓Age 13 to 25 years inclusive
- ✓Diagnosis of childhood-onset GH deficiency with completion of prior GH treatment, evidenced by bone age >14 years (girls) or >16 years (boys), or <0.5 cm height increase in 6 months prior to screening
- ✓Documented GH deficiency by standard provocative test (insulin stimulation <5 ng/mL, or GHRH+arginine <9 ng/mL) at least 30 days after GH discontinuation; or if hypopituitary with ≥2 pituitary disorders and low IGF-1, stimulation test not required
- ✓If hypopituitary, must have been on adequate replacement therapy for glucocorticosteroids, thyroid, and sex hormones (hormone levels normal/mildly elevated) for ≥6 months prior to screening
- ✕Known allergy or hypersensitivity to growth hormone or diluent
- ✕Previous GH treatment within 6 months prior to screening
- ✕Severe illness during the previous 6 months
- ✕Active malignancy (except non-melanomatous skin malignancies)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IIIb, Prospective, Multicenter, Randomized, Open-label Study to Determine the Safety and Efficacy of Two Different Dosing Regimens of Saizen® (Recombinant Human Growth Hormone (r-hGH), Using Cool.Click™ in Subjects With Childhood-onset Growth Hormone Deficiency During the Adolescent Transition Phase (CATS)
In Brief
A Phase 3 clinical trial evaluating recombinant human growth hormone for Childhood-onset Growth Hormone Deficiency and Pituitary Dwarfism. Completed, enrolled 31 participants across 9 sites.
Detailed Summary
The primary objective is to evaluate the efficacy and safety of two different dose regimens of r-hGH (Saizen®) in subjects with childhood-onset growth hormone deficiency (COGHD) during the transition phase from childhood to adulthood.
Study Details
Timeline
Interventions
0.005 mg/kg/day for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
0.010 mg/kg/day for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.