Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)

Study Overview
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Brief Summary
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To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA) without epiphyseal closing.

Official Title
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Long Term Study Of Pnu-180307 For Short Children Born Small For Gestational Age (Sga) Without Epiphyseal Closure (Extension Of The Study 307-met-0021-002)

Conditions
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Short Stature Born Small for Gestational Age (SGA)

Intervention / Treatment
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* Drug: Genotropin (somatropin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with short stature due to SGA who received treatment in the study GENASG-0021-002. Exclusion Criteria: Children who have any chronic disease requiring treatment with steroid hormone that may affect growth promotion including estrogen, androgen, anabolic hormone, and corticosteroids (except those for external use), and have received the treatment. Children who have received radiotherapy or chemotherapy. Children who have serious cardiac disease, renal disease, or hepatic disease. Children who have diabetes mellitus with a manifestation of abnormal glucose metabolism. Children who have serious chronic disease. Children who have malignant tumor. Children who are allergic to m-cresol.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genotropin (somatropin)<br> | Drug: Genotropin (somatropin)<br>* Genotropin(somatoropin) 12 mg, Genotropin(somatropin) will be given at a dose of 0.067 mg/kg/day or 0.033 mg/kg/day to all participating patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | Month 12 (at the end of previous study) to 156 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height Velocity Standard Deviation Score (SDS) for Chronological Age | Height velocity is the yearly height gain. Height velocity SDS is calculated as following formula; Height velocity SDS = (height velocity - mean) / standard deviation, where mean and standard deviation were based on standard Japanese values of the participants age and gender. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender. | Month 12 (at the end of previous study) to 156 | 
| Height Velocity | Height velocity is the yearly height gain | Month 12 (at the end of previous study) to 156 | 
| Height SDS for Chronological Age | Height SDS is calculated as following formula; Height SDS = (height - mean) / standard deviation, where mean and standard deviation were based on standard Japanese values on the participant age and gender. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender. | Month 12 (at the end of previous study) to 156 | 
| Height Velocity SDS for Bone Age | To measure bone age, X-ray images of the left hand were centrally assessed by an independent specialist using the Tanner-Whitehouse 2 (RUS) method standardized for Japanese children. Height velocity is the yearly height gain. Height velocity SDS for bone age is calculated as following formula; Height velocity SDS = (height velocity - mean) / standard deviation, where mean and standard deviation were based on standard Japanese values corresponding to bone age and gender. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender. | Month 12 (at the end of previous study) to 156 | 
| Height SDS for Bone Age | To measure bone age, X-ray images of the left hand were centrally assessed by an independent specialist using the Tanner-Whitehouse 2 (RUS) method standardized for Japanese children. Height SDS for bone age is calculated as following formula; Height SDS = (height - mean) / standard deviation, where mean and standard deviation were based on standard Japanese values corresponding to bone age and gender. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender. | Month 12 (at the end of previous study) to 156 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SGA, Genotropin(somatropin), Short Stature, Long-term, Safety