NCT00699855

Long Term Follow up Study of Predictive Markers in GHD and TS Children

Observational Long-term Follow-up of the Phase IV Open-label Trial of Predictive Markers in GHD and TS Pre-pubertal Children Treated With Saizen

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 182 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Primary objective is to assess the relationship between changes from serum biomarkers observed after 1 month of Saizen® therapy and change in height, weight after up to 5 years of treatment with Growth Hormone in children with Growth Hormone Deficiency (GHD) and Turner Syndrome (TS).

Detailed description

This study is an observational study that will collect data from patients enrolled in a previous study (PREDICT, NCT 00256126). Data such as auxological parameters (height, weight, Tanner stage, bone age will be collected as well as GH treatment use (including dose and adherence to the treatment). Because for some countries the start of this long term follow up study will take place more than one year after subjects have completed the initial study (PREDICT) retrospective data may be collected (if subjects agree) as well as prospective data. When available laboratory parameters such as IGF-1, IGFPB-3, fasting glucose, fasting insulin, TSH and T4 will also be collected. This data will be collected yearly during the normal follow up visits during 5 years.

Conditions

• Growth Hormon Deficiency
• Turner Syndrome in Pre-pubertal Children

Timeline

• Start date: 2008-09-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2008-06-18
• Last updated: 2014-02-19