NCT00256126

Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN®

A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children Treated With SAIZEN®

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 318 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 2 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

The study aims at identifying the predictive markers after one month of Saizen therapy in Growth Hormone Deficiency (GHD) and Turner Syndrome children.

Conditions

• Growth Hormone Deficiency
• Turner Syndrome

Interventions

Type	Name	Description
DRUG	Saizen	Subjects with TS will receive SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month
DRUG	Saizen	Subjects with GHD will receive SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.

Timeline

• Start date: 2005-05-31
• Primary completion: 2007-09-30
• Completion: 2007-09-30
• First posted: 2005-11-21
• Last updated: 2018-06-26
• Results posted: 2018-03-20

Locations

13 sites across 13 countries: Argentina, Australia, Austria, Canada, France, Germany, Italy, Norway, Russia, Singapore, Spain, Sweden, United Kingdom