Observational Study of Somatropin Treatment in Children

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22845 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-04-30

Study Completion Date

2015-09-30

Brief Summary

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GeNeSIS is an open-label, multinational, multicenter, observational study to evaluate the safety and effectiveness of Humatrope treatment.

GeNeSIS is a modular program that includes:

* Core study: Evaluating the safety and effectiveness of Humatrope in the observational setting
* Genetic Analysis Sub-study: Investigating the genetic defects underlying growth hormone (GH) deficiency and non-GH-deficient growth disorders
* Growth Prediction Sub-study: Working to validate and refine specific models to accurately predict growth response to GH
* Short Stature Homeobox containing gene (SHOX) Deficiency Sub-study: Elucidating the clinical, endocrine and radiological features of participants with SHOX deficiency due to loss of, or mutation in the SHOX gene (including participants with Turner syndrome)
* Neoplasia Sub-study: To characterize the natural history of neoplastic disease, especially in relation to recurrence/progression of primary neoplasia or development of secondary neoplasia in children with a history of neoplasia

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Detailed Description

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Conditions

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Growth Hormone (GH) Deficiency Short Stature Homeobox Containing Gene (SHOX) Deficiency SHOX Deficiency-related Disorder Non-GH-deficient Growth Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treated

Participants treated with somatropin for improvement of growth

Somatropin (recombinant deoxyribonucleic acid [rDNA] origin)

Intervention Type DRUG

Dose, frequency and duration at discretion of attending physician.

Untreated

Untreated participants with presence or history of neoplastic disease evaluated for endocrine or growth disorder or with any SHOX deficiency related disorder

No interventions assigned to this group

Interventions

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Somatropin (recombinant deoxyribonucleic acid [rDNA] origin)

Dose, frequency and duration at discretion of attending physician.

Intervention Type DRUG

Other Intervention Names

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Humatrope LY137998

Eligibility Criteria

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Inclusion Criteria

All participants participating in GeNeSIS must be enrolled in the core study. Participants for whom written consent to release information is provided may enter the core study if they meet any of the following inclusion guidelines:

* Treatment with Humatrope for improvement of growth.
* No treatment with somatropin in participants with a history of neoplasia or in those with any SHOX deficiency-related disorder.

Exclusion Criteria

* Participants with closed epiphyses are not eligible for GeNeSIS entry. However, participants may remain in the study if epiphyseal closure occurs during study participation.

Minimum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No