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drugset / Trial / NCT01067352

A Trial to Evaluate the Correlation Between Spontaneous Catch-up Growth, Clinical Response to Saizen (Recombinant Human Growth Hormone, r-hGH) and Gene Expression Profiling in Children Small for Gestational Age (SGA)

NCT01067352 ↗

Phase 3 Terminated 25 enrolled Merck KGaA, Darmstadt, Germany Merck Serono S.P.A., Italy · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This open, multicentric, randomized, controlled study is planned to evaluate the correlation between gene expression, spontaneous catch-up growth and therapeutic response to Saizen in SGA children.

Timeline

Start
2004-02
Primary completion
2009-07
Completion
2009-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Somatropin Protein / enzyme biologic 0.035 mg/kg Subcutaneous
Subject Somatropin Protein / enzyme biologic 0.067 mg/kg Subcutaneous

Indications

fetal growth restriction