At a glance
ClinicalIndex Comparison Record- ✓Height velocity less than 25th percentile at diagnosis
- ✓Confirmed diagnosis of growth hormone deficiency
- ✓Prior GH replacement at in-label dosage (0.025–0.035 mg/kg/day) for 1–3 years before enrollment
- ✓Bone age <12 years for girls, <14 years for boys (assessed by central reader)
- ✕Active malignancy; if prior diencephalic/hypophysial tumor resection, MRI within 6 months must exclude residual growth
- ✕Chronic diseases: diabetes mellitus, hepatic disease (liver enzymes >3× upper limit of normal), renal disease (creatinine >130 micromol/L), or congestive heart failure
- ✕Glucocorticoid therapy at supraphysiological doses (inhaled ≤3 puffs/day for ≤10 consecutive days allowed)
- ✕Prior or concurrent therapy with agents affecting growth: GHRH, estrogens, or anabolic steroids
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety of a High Dosage Compared to the Label Dosage of Humatrope in Early Pubertal Stage Children With Growth Hormone Deficiency
In Brief
A Phase 3 clinical trial evaluating Somatropin for Growth Hormone Deficiency. Completed, enrolled 27 participants across 10 sites.
Detailed Summary
Multi-center, randomized, controlled, open-label, phase III study comparing the effects of two different dosages of somatropin treatment (in-label or doubled) after 12 and 24 months of treatment, on height velocity in early pubertal children with growth hormone deficiency (GHD). The study will be conducted in Italy. Approximately 26 subjects will participate in this study, distributed as 13 in the in-label dosage group (group A) and 13 in the doubled dosage group (group B).
Study Details
Timeline
Interventions
Doubled dosage with respect to the pre-enrollment (in-label) dosage
In-label dosage