Non-Interventional Octagam® 10% - GAM10-06 "GammaTrack"

Condition(s) targeted: Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIG

Intervention: Octagam IVIG 5% or 10% (Biological)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Octapharma

Official(s) and/or principal investigator(s):
David Barnes, MD, Study Director, Affiliation: Octapharma

Overall contact:
Lidia Cosentino, Phone: (416) 531 5533, Email: lidia.cosentino@octapharma.com

Non-Interventional Study on the Tolerability and Efficacy of octagam® 10%

Official title: Non-Interventional Study on the Tolerability and Efficacy of Octagam® 10% - GAM10-06 "GammaTrack"

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Adverse Drug Reactions

Secondary outcome: Rate of Infection Occurrence

Detailed description: A Non-Interventional Study on the Tolerability and Efficacy of octagam® 10%. Patients with any indication (replacement and immonomodulation) as described by the treating physician. Marketed Octagam 5% or 10% will be used according to the investigator prescription; intravenous (iv) administration. The primary objective is to detect and evaluate adverse drug reactions (ADRs) occurring during or after the administration of Octagam in any indication, age group or treatment regimen, where a causal relationship to the administration of Octagam is suspected.

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Any patient who needs to be treated with a product of this class because of his/her

medical condition and whom the treating physician decides to prescribe Octagam regularly, may be included. Exclusion Criteria:

- None

Lidia Cosentino, Phone: (416) 531 5533, Email: lidia.cosentino@octapharma.com

Starting date: September 2015
Last updated: June 5, 2015