Post-Authorisation Safety Study (PASS) of CLAIRYG® (Human normal immunoglobulin for intravenous use) in children under 12 years treated for primary immunodeficiency (PID) or immune thrombocytopenic purpura (ITP) (IGNGPASSP)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33321
• EU PAS number:
  EUPAS33320
• Study ID:
  33321
• Official title and acronym:
  Post-Authorisation Safety Study (PASS) of CLAIRYG® (Human normal immunoglobulin for intravenous use) in children under 12 years treated for primary immunodeficiency (PID) or immune thrombocytopenic purpura (ITP) (IGNGPASSP)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  The primary objective is to evaluate the safety of CLAIRYG® administered as part of common practice in children under 12 years treated for PIDs or ITP over a follow-up period of 12 months. The secondary objectives are as follows: - To describe the conditions of use of CLAIRYG® as part of common practice in children under 12 years, - And to collect efficacy data to better document the benefit/risk ratio in the two pathologies studied: PIDs and ITP.
• Study status:
  Finalised

Research institution and networks

Institutions

LFB - Paris-Saclay

Bordeaux University Hospital (CHU de Bordeaux)

France

Necker Hospital PARIS, University Hospital ROUEN, Pellegrin Hospital BORDEAUX, Jeanne de Flandre Hospital LILLE, University Hospital ANGERS, Brabois Hospital NANCY

Study timelines

Date when funding contract was signed

Actual: 15/07/2014

Study start date

Actual: 26/10/2015

Date of interim report, if expected

Actual: 17/12/2020

Date of final study report

Actual: 02/02/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

LFB

Study protocol

Initial protocol

Protocole_ClairYg_ final_V 3 0_2015_01_27 (EN) anonymisé

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable