A prospective Phase III, Multicentre, Randomised, Open Label Study to Evaluate the Comparitive Safety and Efficacy of Recombinant Human Growth Hormone (rhGH) of USV with Eutropin in the Treatment of Pre-pubertal Children (4 to 12 years) with Growth Hormone Deficency

SV Ltd0 sites60 target enrollmentTBD

ConditionsHealth Condition 1: null- Growth hormone deficiency in pre-pubertal children(4 to 12 years).

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Health Condition 1: null- Growth hormone deficiency in pre-pubertal children(4 to 12 years).
Sponsor: SV Ltd
Enrollment: 60
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Investigators

Sponsor

SV Ltd

Eligibility Criteria

Inclusion Criteria

•1\. Pre\-pubertal children in the age group of 4\-12 years of age.
•2\. Children with short stature with a growth rate 5\.0 cm per year.
•3\.Children with deficiency of GH testing without any organic pathology documented by dynamic GH testing by at least 2 differnent stimuli.The post stimulation level of human GH should not be / 10 ng/ml.
•4\. GH defiency if due to pituitary surgery not earlier than 2 years and woth a stable disease.

Exclusion Criteria

•1\.Associated endocrine disorders of thyroid function, adenocortical insufficiency(serum basal cortisol\<3ug/dl) unless adequately replaced with thyroxin and showing a stable thyroid function at least for 8 weeks.
•2\.patients already receiving rhGH treatment
•3\. Known hypersenitivity to the Investigational products
•4\.Any systemic disorder likely to affect pharmacological action of somatropin.

Outcomes

Primary Outcomes

Not specified

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