At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 318 enrolled

Drug / intervention

Saizen +1 moredrug

Likely dose

Saizen 0.050 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.

Search/NCT00256126

NCT00256126Phase 4Completed

Compare CT.gov

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

Merck KGaA, Darmstadt, Germany·interventional·Posted Nov 21, 2005·Updated Jun 26, 2018

In Brief

A Phase 4 clinical trial evaluating Saizen for Growth Hormone Deficiency and Turner Syndrome. Completed, enrolled 318 participants across 13 sites in 13 countries.

Detailed Summary

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

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsGrowth Hormone Deficiency, Turner Syndrome

CountriesArgentina, Australia, Austria, Canada, France, Germany, Italy, Norway, Russia, Singapore, Spain, Sweden, United Kingdom

Collaborators--

Timeline

Phase 4CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMay 2005

First PostedNov 2005

Primary CompletionSep 2007

TodayJul 2026

First PostedNov 21, 2005

Enrollment StartMay 31, 2005

Primary CompletionSep 30, 2007

TodayJul 2, 2026

Enrollment to primary: 2.3 yearsPosted 20.6 years ago

Interventions

Saizendrug

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

Saizendrug

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.