A Phase 3 Study to Evaluate the Safety and Efficacy of Saizen® in Children With Idiopathic Short Stature (ISS)

PHASE3CompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

December 31, 2012

Primary Completion Date

August 31, 2014

Study Completion Date

March 31, 2015

Conditions
Idiopathic Short Stature
Interventions
DRUG

Saizen®

Subjects in the Saizen test group will receive Saizen (recombinant-human growth hormone \[r-hGH\]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.

DRUG

Saizen®

Subjects in the Saizen control group will receive no treatment for the first 6 months and thereafter will receive Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.

Trial Locations (1)

Unknown

Please contact Merck KGaA Communication Center for Recruiting Sites, Located in

All Listed Sponsors
lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT01746862 - A Phase 3 Study to Evaluate the Safety and Efficacy of Saizen® in Children With Idiopathic Short Stature (ISS) | Biotech Hunter | Biotech Hunter