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

Merck KGaA (EMD Serono)

Status: Completed

Conditions: Infant, Small for Gestational Age

Treatments: Drug: recombinant somatropin

Study type: Observational

Funder types: Industry

Identifiers

NCT01082354

IMP28018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Short children born SGA requiring treatment with Saizen, new to growth hormone treatment or being treated with growth hormones for less than 12 months of inclusion
• Subjects whose parents have given their written consent for participation in this study

Exclusion criteria

• Contra-indication in the treatment with Saizen