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Observational Study of Somatropin Treatment in Children

NCT01088412 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 22845

Last updated 2019-05-13

Study results available
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Summary

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

Conditions

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

Interventions

DRUG

Somatropin (recombinant deoxyribonucleic acid [rDNA] origin)

Dose, frequency and duration at discretion of attending physician.

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Eligibility

Min Age
1 Day
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-04-30
Primary Completion
2015-09-30
Completion
2015-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01088412 on ClinicalTrials.gov