NCT03831880

Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD

A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN (REGISTERED)) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	Genotropin	Genotropin (dose \[mg\] at time of enrollment) given subcutaneously once daily
DRUG	somatrogon	0.66 mg/kg/week given subcutaneously once weekly

Timeline

• Start date: 2019-02-07
• Primary completion: 2020-08-28
• Completion: 2020-08-28
• First posted: 2019-02-06
• Last updated: 2021-10-14
• Results posted: 2021-10-14

Locations

32 sites across 5 countries: United States, Bulgaria, Czechia, Slovakia, United Kingdom

Regulatory

• FDA-regulated drug study