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| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS7948 | Registry Identifier | EU PAS Register |
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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.
The objective of this study is to collect long term safety and effectiveness information on Ipsen's growth hormone (GH) NutropinAq® regarding treatment of paediatric growth disorders for which GH is indicated.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment height measurements until epiphyseal closure is achieved. | Every 3 months until study completion |
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Inclusion Criteria:
Exclusion Criteria:
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Children treated with NutropinAq in the specialised paediatric endocrinology centres
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ipsen Central Contact | Slough | Berkshire | SL1 3XE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34113318 | Derived | Coutant R, Bosch Munoz J, Dumitrescu CP, Schnabel D, Sert C, Perrot V, Dattani M. Effectiveness and Overall Safety of NutropinAq(R) for Growth Hormone Deficiency and Other Paediatric Growth Hormone Disorders: Completion of the International Cooperative Growth Study, NutropinAq(R) European Registry (iNCGS). Front Endocrinol (Lausanne). 2021 May 25;12:676083. doi: 10.3389/fendo.2021.676083. eCollection 2021. |
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