International Cooperative Growth Study Post Marketing Surveillance Program For Nutropin Aq® [Somatropin (rDNA Origin) Injection] (iNCGS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/30502
• EU PAS number:
  EUPAS7948
• Study ID:
  30502
• Official title and acronym:
  International Cooperative Growth Study Post Marketing Surveillance Program For Nutropin Aq® [Somatropin (rDNA Origin) Injection] (iNCGS)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  France

  Germany

  Italy

  Romania

  Spain

  United Kingdom
• Study description:
  The objective of this study is to collect long term safety and efficacy information on Ipsen’s growth hormone (GH) NutropinAq® during treatment of pediatric growth disorders for which GH is indicated. International multicenter, open label, observational, post-marketing surveillance study, duration open ended, patients participation: until fusion of the epiphyses (end of growth period). Patients initiating therapy or currently receiving therapy with NutropinAq® for paediatric growth disorders and meeting eligibility criteria will be proposed to enter in the registry. The aim is to recruit as many patients as possible in the participating sites to obtain a sample that is representative of the treated population. Inclusion criteria:Patients must meet the following criteria:• Children of either sex who are initiating therapy or currently receiving therapy with NutropinAq® for the treatment of growth failure • 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• Patients who are willing to comply with follow up appointments throughout study participation.
• Study status:
  Finalised

Research institutions and networks

Institutions

Ipsen Pharma

Multiple centres: 158 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 01/06/2006

Actual: 01/06/2006

Study start date

Planned: 01/06/2006

Actual: 01/06/2006

Date of interim report, if expected

Planned: 14/06/2016

Actual: 14/06/2016

Date of final study report

Planned: 31/12/2017

Actual: 22/12/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

IPSEN Pharma

Study protocol

Initial protocol

2-79-58035-005-protocol-20140715_Redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)