ADVATE 2 mL (reconstituted in 2 mL SWFI) POST-AUTHORIZATION SAFETY SURVEILLANCE STUDY (ADVATE 2 mL PASS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/46476
• EU PAS number:
  EUPAS7331
• Study ID:
  46476
• Official title and acronym:
  ADVATE 2 mL (reconstituted in 2 mL SWFI) POST-AUTHORIZATION SAFETY SURVEILLANCE STUDY (ADVATE 2 mL PASS)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  Estonia

  France

  Germany

  Hungary

  Portugal

  United Kingdom
• Study description:
  This is a Post-Authorization Safety Surviellance (PASS) study designed to collect data on the safety and effectiveness of ADVATE reconstituted in 2 mL Sterile Water for Injection (SWFI) during routine clinical practice in children ≤12 years of age.
• Study status:
  Finalised

Research institutions and networks

Institutions

Shire

Multiple centres: 30 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 23/02/2012

Actual: 23/02/2012

Study start date

Planned: 20/09/2013

Actual: 20/09/2013

Data analysis start date

Planned: 31/05/2016

Actual: 18/03/2016

Date of final study report

Planned: 30/09/2016

Actual: 30/09/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Baxalta, now part of Shire

Study protocol

Initial protocol

061101-protocol-amend-1-2013jul26_redacted_final_20170223

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 2 (specific obligation of marketing authorisation)