MedTrace Logo

Long-term Safety Follow-up After Growth Hormone Treatment of Short Children Born Small for Gestational Age

NCT01491854 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2019-08-14

Study results available
· View outcomes & findings →

Summary

This study is performed as part of the Marketing Authorisation Holder's post-marketing pharmacovigilance plan 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).

Conditions

  • Short Children Born Small for Gestational Age (SGA)

Interventions

OTHER

Bloodsampling

Bloodsampling

Sponsors & Collaborators

Principal Investigators

  • Sandoz Biopharmaceuticals Sandoz · Sandoz GmbH

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-20
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • Czechia
  • Georgia
  • Germany
  • Hungary
  • Poland
  • Romania

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01491854 on ClinicalTrials.gov