A Post-Marketing Safety Study to Evaluate the Occurrence of Aseptic Meningitis Syndrome (AMS) in an Adult Population (>= 18 Years) Treated with Doses of >= 1g/kg Intragam® 10 NF

Study identification

• EU PAS number:
  EUPAS17881
• Study ID:
  20904
• Official title and acronym:
  A Post-Marketing Safety Study to Evaluate the Occurrence of Aseptic Meningitis Syndrome (AMS) in an Adult Population (>= 18 Years) Treated with Doses of >= 1g/kg Intragam® 10 NF
• DARWIN EU® study:
  No
• Study countries:
  Australia
• Study description:
  This is a prospective observational study in patients treated with Intragam 10 NF. Patients who are naïve to IVIg (Intravenous immunoglobulin) or who change to Intragam 10 NF from an alternative immunoglobulin product will be invited to participate in the study. Study participants will be required to report any adverse events of AMS, migraine and severe headache during their infusion, during their treatment course, or within 7 days of their last infusion, to the treatment centre.
• Study status:
  Ongoing

Research institutions and networks

Institutions

CSL Behring

Gold Coast Hospital Southport, Australia, Royal Melbourne Hospital Parkville, Australia, Royal Adelaide Hospital Adelaide, Australia, Concord Repatriation General Hospital Concord, Australia, Canberra Hospital Canberra, Australia, Hollywood Private Hospital Nedlands WA

Study timelines

Date when funding contract was signed

Planned: 31/08/2016

Actual: 31/08/2016

Study start date

Planned: 01/03/2017

Actual: 03/04/2017

Date of final study report

Planned: 30/06/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

CSL Limited

Regulatory

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