drugset / Trial / NCT01187550
Predictive Markers in Chinese Growth Hormone Deficiency (GHD) Children Treated With Saizen®
Phase 4
Completed
214 enrolled
Merck KGaA, Darmstadt, Germany
Merck Serono Co., Ltd., China · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-03
- Primary completion
- 2008-09
- Completion
- 2009-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Somatropin | Protein / enzyme biologic | 0.033 mg/kg | Subcutaneous |