Study identification

EU PAS number

EUPAS15717

Study ID

16405

Official title and acronym

The Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS) (GeNeSIS B9R-EW-GDFC)

DARWIN EU® study

No

Study countries

Australia
Austria
Belgium
Canada
Czechia
Denmark
Finland
France
Germany
Greece
Hungary
Iceland
India
Italy
Japan
Kazakhstan
Lithuania
Luxembourg
Netherlands
Norway
Pakistan
Russian Federation
Singapore
Slovakia
South Africa
Spain
Sweden
Taiwan
Thailand
United Kingdom
United States

Study description

Growth failure and short stature during childhood is a frequent cause of referral to a paediatric endocrinologist and may lead to treatment with somatropin.  Since the launch of somatropin in the late 1980s, there has been considerable discussion regarding the potential influence of growth hormone (GH) therapy on a variety of safety outcomes, most notably neoplasia due to the general growth-inducing effects of GH.  The primary aim of GeNeSIS, which started in 1999, was to monitor the safety and effectiveness of somatropin in paediatric patients with growth failure and short stature in the real-world setting.  Untreated patients were also included in specific subpopulations if they were diagnosed with short stature homebox containing gene deficiency (SHOX-D) or had history of neoplastic disease.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Christopher Child

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Actual:

Date of interim report, if expected

Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable