Observational Study of Somatropin Treatment in Children

Plain-language summary

This observational study examines Somatropin (growth hormone, Humatrope) treatment used to support growth in children. It enrolled children receiving Humatrope therapy to improve growth. This study had no assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

Eli Lilly and Company

Intervention

Somatropin (recombinant deoxyribonucleic acid [rDNA] origin)

Start date

4/1/1999

Estimated completion

9/1/2015

Related genes

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.