GH-4831: CROITRE Registry :French registry of children treated with Norditropin® for short stature associated with Noonan Syndrome

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/46845
• EU PAS number:
  EUPAS46223
• Study ID:
  46845
• Official title and acronym:
  GH-4831: CROITRE Registry :French registry of children treated with Norditropin® for short stature associated with Noonan Syndrome
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  This is a non-interventional registry of children treated with Norditropin® for short stature due to Noonan Syndrome (NS). This study aims to provide data on long-term growth evolution and safety of Norditropin® as well as Health Related Quality of Life (HRQoL) data. This registry will include the entirety of children treated with Norditropin® for short stature due to NS over the inclusion period. The decision to initiate treatment with commercially available Norditropin® is made by the patient/parents/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Novo Nordisk

CHU de Toulouse - Hôpital des Enfants

HOPITAL DE BICETRE 78, avenue du Général Leclerc, LE KREMLIN-BICETRE, Hôpital des Enfants Hôpital des Enfants 330 avenue de Grande-Bretagne, Toulouse cedex 9

Study timelines

Date when funding contract was signed

Planned: 21/02/2022

Study start date

Planned: 16/03/2022

Actual: 16/03/2022

Date of final study report

Planned: 17/03/2029

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novo Nordisk A/S

Study protocol

Initial protocol

4831 protocol eu-pas-reg redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

UTN:U1111-1264-1805