Efficacy and Safety Evaluation of Recombinant Human Growth Hormone (r-hGH), Saizen®, on a Population of Children With Hypochondroplasia, Treated at Least 3 Years or Until Near Final Height, When Applicable, in Comparison With a Historic Cohort of Non-treated Children

PHASE2CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

March 21, 2006

Primary Completion Date

January 17, 2017

Study Completion Date

January 17, 2017

Conditions
Hypochondroplasia
Interventions
DRUG

Recombinant human growth hormone (r-hGH)

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.

Trial Locations (1)

75015

Endocrinologie Pédiatrique - centre des maladies rares de la croissance -Hôpital Necker Enfants Malades, Paris

All Listed Sponsors
collaborator

Merck Serono S.A.S, France

INDUSTRY

lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT01111019 - Efficacy and Safety Evaluation of Recombinant Human Growth Hormone (r-hGH), Saizen®, on a Population of Children With Hypochondroplasia, Treated at Least 3 Years or Until Near Final Height, When Applicable, in Comparison With a Historic Cohort of Non-treated Children | Biotech Hunter | Biotech Hunter