CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 214 enrolled
Drug / intervention
Recombinant human growth hormone (r-hGH)drug
Likely dose
Recombinant human growth hormone (r-hGH) 0.033 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/NCT01187550
NCT01187550Phase 4Completed
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A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient Pre-pubertal Children Treated With Saizen®

Merck KGaA, Darmstadt, Germany·interventional·Posted Aug 24, 2010·Updated Feb 13, 2014

In Brief

A Phase 4 clinical trial evaluating Recombinant human growth hormone (r-hGH) for Dwarfism, Pituitary. Completed, enrolled 214 participants.

Detailed Summary

This is an open-label, prospective, multicentric, non-comparative, non-randomized Phase IV interventional study in which subjects pre-diagnosed with Growth Hormone Deficiency (GHD) were treated for 4 weeks with Saizen to compare the response between GHD children born appropriate for gestational age (AGA) and those born small for gestation age (SGA) after 4 weeks of Saizen therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDwarfism, Pituitary
Countries--
CollaboratorsMerck Serono Co., Ltd., China

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 24, 2010
Enrollment StartMar 1, 2007
Primary CompletionSep 1, 2008
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 15.9 years ago

Interventions

Recombinant human growth hormone (r-hGH)drug

Recombinant human growth hormone (r-hGH) administered at dose of 0.033 milligram/kilogram (mg/kg) body weight (0.1 International Unit \[IU\]/kg body weight) per day by subcutaneous injection.