Conditions: Growth Hormone Deficiency
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 87
Healthy volunteers: no

Brief summary:
This is an open label randomized 24 week crossover trial assessing the treatment burden of a weekly growth hormone injection regimen (somatrogon) compared to a daily growth hormone injection regimen (Genotropin). Approximately 90 children with growth hormone deficiency who have been stable on treatment with daily Genotropin will be enrolled.

Detailed description:
Subjects will be randomized to one of two sequences, either 12 weeks of continued treatment with daily Genotropin followed by 12 weeks of treatment with weekly somatrogon, or 12 weeks of treatment with weekly somatrogon followed by 12 weeks of treatment with daily Genotropin. Subjects will have study visits at Baseline, Weeks 6, 12, 18, and 24. Subjects will also be followed up by phone 8 to 12 days after each treatment period begins (Week 1 and Week 13). Subjects and caregivers (as a Dyad) will complete questionnaires assessing treatment burden at baseline and at the end of each 12 week treatment period. All subjects/caregivers will receive a follow up phone call at Week 28.

Arms:
arm 1: Genotropin to somatrogon arm 2: somatrogon to Genotropin

Interventions: intervention 1: Genotropin intervention 2: somatrogon
Intervention descriptions: intervention 1: Genotropin (dose \[mg\] at time of enrollment) given subcutaneously once daily intervention 2: 0.66 mg/kg/week given subcutaneously once weekly

Protocol document:
Prot_000.pdf: 















































































































































































































SAP_001.pdf: