A Post-Marketing Safety Study to Evaluate the Occurrence of Aseptic Meningitis Syndrome (AMS) in an Adult Population Treated with Intragam® 10 NF

CONDITION

Blood

GENDER

Both males and females

AGE GROUP

From 18

and above

STATUS

Terminated

The purpose of this study is to collect data. The sponsor will be collecting medical information from study participants (through an interview and a phone call up to 7 days after the last infusion) to evaluate the occurrence of Aseptic Meningitis Syndrome (AMS) in an adult population (≥ 18 years of age) treated with ≥1g/kg Intragam 10.

AMS is an illness characterized by inflammation of the linings of the brain. Symptoms vary, with headache and fever most common. The illness is usually mild and runs its course without treatment; however, some cases can be severe.

The study will be performed in Australia in about 15 centres and approximately 200 patients will be enrolled in the study.

 

CONTACT DETAILS

Phone Number: (08) 9446 8726

Email: info@affinityresearch.com.au

Location: 52/85 Monash Avenue, Nedlands, Western Australia, Australia

Approved By: Bellberry Limited              

Clinical Trial Registry Link: