At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 87 enrolled
Drug / intervention
Genotropin +1 moredrug
Likely dose
somatrogon 0.66 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Genotropin and somatrogon for Growth Hormone Deficiency. Completed, enrolled 87 participants across 32 sites in 5 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGrowth Hormone Deficiency
CountriesBulgaria, Czechia, Slovakia, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedFeb 2019
Enrollment StartFeb 2019
Primary CompletionAug 2020
TodayJul 2026
First PostedFeb 6, 2019
Enrollment StartFeb 7, 2019
Primary CompletionAug 28, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.4 years ago
Interventions
Genotropindrug
Genotropin (dose \[mg\] at time of enrollment) given subcutaneously once daily
somatrogondrug
0.66 mg/kg/week given subcutaneously once weekly