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

January 4, 2019 updated by: Ipsen

International Cooperative Growth Study (iNCGS) Post Marketing Surveillance Program for NutropinAq® [Somatropin (rDNA Origin) Injection]

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.

Study Overview

Status

Completed

Conditions

Growth Hormone Disorders

Detailed Description

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 (Actual)

3690

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United Kingdom
- Berkshire
  - Slough, Berkshire, United Kingdom, SL1 3XE
    - Ipsen Central Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children treated with NutropinAq in the specialised paediatric endocrinology centres

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events Time Frame: Every 3 months until study completion	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 Outcome Measures

Outcome Measure	Time Frame
Treatment height measurements until epiphyseal closure is achieved. Time Frame: Every 3 months until study completion	Every 3 months until study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2006

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)