Conditions: Pediatric Growth Hormone Deficiency
Keywords: GHD r-hGH Long-acting
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 56
Healthy volunteers: no

Brief summary:
This is a phase II, open label, active-controlled, randomized safety and dose finding study of different MOD-4023 dose levels compared to daily r-hGH therapy in pre-pubertal growth hormone deficient children.

Detailed description:

Arms:
arm 1: Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) arm 2: Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) arm 3: Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) arm 4: Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)

Interventions: intervention 1: MOD-4023 intervention 2: Somatropin
Intervention descriptions: intervention 1: Once weekly subcutaneous injection intervention 2: Once daily subcutaneous injection of Genotropin

Protocol document: