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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck Serono S.A.S, France

Criteria

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