At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 19 enrolled
Drug / intervention
Recombinant human growth hormone (r-hGH)drug
Likely dose
Recombinant human growth hormone (r-hGH) 0.057 milligramfrom 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.
Efficacy and Safety Evaluation of Recombinant Human Growth Hormone (r-hGH), Saizen®, on a Population of Children With Hypochondroplasia, Treated Over a Period of 3 Years or 5 Years if Applicable, in Comparison With a Historic Cohort of Non-treated Children With Hypochondroplasia
In Brief
A Phase 2 clinical trial evaluating Recombinant human growth hormone (r-hGH) for Hypochondroplasia. Completed, enrolled 19 participants across 1 site.
Detailed Summary
This study is conducted to describe the efficacy and safety of recombinant human growth hormone (r-hGH) treatment Saizen® on children with hypochondroplasia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypochondroplasia
CountriesFrance
CollaboratorsMerck Serono S.A.S, France
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2006
First PostedApr 2010
Primary CompletionJan 2017
TodayJul 2026
First PostedApr 27, 2010
Enrollment StartMar 21, 2006
Primary CompletionJan 17, 2017
TodayJul 2, 2026
Enrollment to primary: 10.8 yearsPosted 16.2 years ago
Interventions
Recombinant human growth hormone (r-hGH)drug
Subjects will receive a single subcutaneous injection of recombinant human growth hormone (r-hGH) equivalent to a dose of 0.057 milligram per kilogram per day (mg/kg/day). The dose will be subsequently adjusted during the trial and subjects will be treated for at least 3 years or until near final height is reached.