NCT01082354

A Pharmaco-epidemiological Study of Short Patients Born Small for Gestational Age (SGA), Treated With Saizen® (Recombinant Somatropin)

Non Interventional Study on the Follow-up, by Specialists, of Short Children Born Small for Gestational Age and Treated With SAIZEN®- SEPAGE Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This one-arm, multi-centric, non-randomized, observational, open label, prospective study was designed to study short subjects born SGA, by pediatricians, endocrinologists or physicians in private, mixed private and hospital practice treated with Saizen.

Detailed description

The term "small for gestational age" (SGA) is a pathological medical condition known since about two decades supported by two consensus conferences of 2001. It inhibits the height and/or weight of the child at birth without prejudging the mechanisms that alter these. This study will be carried out by hospital pediatricians, endocrinologists or physicians in private, mixed private and hospital practice in metropolitan France. Subjects will be monitored by doctors in accordance with the normal scope of follow-up of pathology until their final growth and until they reach adult height and/or until the treatment is discontinued. The participating doctors will include all the short SGA subjects coming for consultation or the follow-up (for less than 12 months) of their treatment by Saizen in this study. The inclusions will take place over a period of 21 months. OBJECTIVES Primary objective: * To describe the characteristics of short children born SGA (SGA subjects) treated with Saizen Secondary objectives: * To describe the terms and conditions for the prescription of Saizen in terms of dosage, duration of treatment, reason for discontinuation and compliance * To describe the effects of Saizen on growth and final height * To describe the tolerance of Saizen. For each subject and during each visit, the participating doctor will complete an electronic data collection form.

Conditions

• Infant, Small for Gestational Age

Interventions

Type	Name	Description
DRUG	recombinant somatropin	as per standard practice

Timeline

• Start date: 2009-03-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2010-03-08
• Last updated: 2016-02-12

Locations

40 sites across 1 country: France