Long Term Follow up Study of Predictive Markers in GHD and TS Children (PREDICT LT FUP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00699855|
Recruitment Status : Completed
First Posted : June 18, 2008
Last Update Posted : February 19, 2014
|Condition or disease|
|Growth Hormon Deficiency Turner Syndrome in Pre-pubertal Children|
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.
|Study Type :||Observational|
|Actual Enrollment :||182 participants|
|Official Title:||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|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
- 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). [ Time Frame: Yearly ]
- When available laboratory parameters such as IGF-1, IGFPB-3, fasting glucose, fasting insulin, TSH and T4 will also be collected. [ Time Frame: Yearly ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699855
|Study Director:||Gilles Della Corte||Merck Serono S.A., Geneva|