NCT00537914

Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)

Long-term Phase IV Multicentre Study on the Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 278 (actual)
• Sponsor: Sandoz · Industry
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

Summary

This study is performed to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in short children born small for gestational age (SGA).

Detailed description

Prospective, open label, non-comparative, multicenter study. Short children born SGA were to be treated until they reached final height, but treatment could be discontinued earlier if medically indicated or if there was inadequate response to treatment.

Conditions

• Small for Gestational Age

Interventions

Type	Name	Description
DRUG	Omnitrope	All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits.

Timeline

• Start date: 2008-02-06
• Primary completion: 2022-03-25
• Completion: 2022-03-25
• First posted: 2007-10-02
• Last updated: 2024-03-12
• Results posted: 2024-03-12

Locations

31 sites across 7 countries: Belgium, Czechia, Georgia, Germany, Hungary, Poland, Romania