A Post Marketing Surveillance Program for NutropinAq® in Paediatric Growth Disorders

Ipsen3,690 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

3,690

Conditions

Growth Hormone Disorders

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ipsen Central Contact

Slough, Berkshire, United Kingdom

Outcomes

Primary Outcomes

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).

Time frame: Every 3 months until study completion

Secondary Outcomes

Treatment height measurements until epiphyseal closure is achieved.

Time frame: Every 3 months until study completion

Data from ClinicalTrials.gov

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