Growth Hormone Disorders Clinical Trial
— iNCGSOfficial title:
International Cooperative Growth Study (iNCGS) Post Marketing Surveillance Program for NutropinAq® [Somatropin (rDNA Origin) Injection]
Verified date | January 2019 |
Source | Ipsen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study is a multicenter, open label, observational, post marketing surveillance study of NutropinAq® in Austria, France, Germany, Italy, Spain, Romania and United Kingdom to collect long-term safety and effectiveness information on NutropinAq® during treatment of paediatric growth disorders.
Status | Completed |
Enrollment | 3690 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility |
Inclusion Criteria: - Children of either sex who are treated with NutropinAq® for the treatment of growth failure - Patients who are willing to comply with follow-up appointments throughout study participation - Written informed consent signed by both parents or by the liable parent or by the legal guardian when applicable, and by the child when applicable Exclusion Criteria: - Patients not treated with NutropinAq® - Patients with closed epiphyses - Patients with active neoplasia |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Ipsen Central Contact | Slough | Berkshire |
Lead Sponsor | Collaborator |
---|---|
Ipsen |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with adverse events | Description and incidence of any Serious Adverse Event (SAE) and all related (serious and non-serious) Adverse Events (AEs). | Every 3 months until study completion | |
Secondary | Treatment height measurements until epiphyseal closure is achieved. | Every 3 months until study completion |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00455884 -
A Post Marketing Surveillance Study for NutropinAq® in Adults With Growth Hormone Deficiency
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