CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 22,845 enrolled
Drug / intervention
Somatropin (recombinant deoxyribonucleic acid [rDNA] origin)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01088412
NCT01088412N/ACompleted

The Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS)

Eli Lilly and Company·observational·Posted Mar 17, 2010·Updated May 13, 2019

In Brief

An observational study evaluating Somatropin (recombinant deoxyribonucleic acid [rDNA] origin) for Growth Hormone (GH) Deficiency and 3 related conditions. Completed, enrolled 22,845 participants.

Detailed 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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 17, 2010
Enrollment StartApr 1, 1999
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 16.4 yearsPosted 16.3 years ago

Interventions

Somatropin (recombinant deoxyribonucleic acid [rDNA] origin)drug

Dose, frequency and duration at discretion of attending physician.