Clinical trial NCT02303093: Non-Interventional Study on the Tolerability and Efficacy of IVIG
Official title: Non-Interventional Study on the Tolerability and Efficacy of IVIG
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIG
Lead sponsor: Octapharma
Sponsor class: INDUSTRY
First posted: 2014-11-27
Enrollment: 344
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 or panzyga regularly, may be included.

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

Detailed description: A Non-Interventional Study on the Tolerability and Efficacy of Octagam 5% or 10% or panzyga. Patients with any indication (replacement and immonomodulation) as prescribed by the treating physician. Marketed Octagam 5% or 10% or panzyga 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 or panzyga in any indication, age group or treatment regimen, where a causal relationship to the administration of Octagam or panzyga is suspected.

Eligibility 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 or panzyga regularly, may be included.

Exclusion Criteria:

* None

Primary outcomes:
measure: Adverse Drug Reactions
timeFrame: up to one year
Secondary outcomes:
measure: Infection Occurrence
timeFrame: Up to one year
Other outcomes:
Locations:
city: Gmunden
country: Austria
facility: Octapharma Research Site
city: Graz
country: Austria
facility: Octapharma Research Site
city: Klagenfurt
country: Austria
facility: Octapharma Research Site
city: Oberndorf
country: Austria
facility: Octapharma Research Site
city: Salzburg
country: Austria
facility: Octapharma Research Site
city: Wien
country: Austria
facility: Octapharma Research Site
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
city: Argenteuil
country: France
facility: Octapharma Research Site
city: Bourges
country: France
facility: Octapharma Research Site
city: Béziers
country: France
facility: Octapharma Research Site
city: Caen
country: France
facility: Octapharma Research Location
city: Caen
country: France
facility: Octapharma Research Site
city: La Rochelle
country: France
facility: Octapharma Research Site
city: Marseille
country: France
facility: Octapharma Research Site
city: Marseille
country: France
facility: Octapharma Research Location
city: Marseille
country: France
facility: Octapharma Research Site
city: Marseille
country: France
facility: Octapharma Research Center
city: Montauban
country: France
facility: Octapharma Research Site
city: Nantes
country: France
facility: Octapharma Research Site
city: Nevers
country: France
facility: Octapharma Research Site
city: Pessac
country: France
facility: Octapharma Research Site
city: Pierre-Bénite
country: France
facility: Octapharma Research Site
city: Rennes
country: France
facility: Octapharma Research Site
city: Toulouse
country: France
facility: Octapharma Research Site
city: Barcelona
country: Spain
facility: Octapharma Research Site
city: Madrid
country: Spain
facility: Octapharma Research Site
city: Madrid
country: Spain
facility: Octapharma Research Location
city: Madrid
country: Spain
facility: Octapharma Research Site
city: Madrid
country: Spain
facility: Octapharma Research Site
city: Leeds
country: United Kingdom
facility: Octapharma Research Site
city: London
country: United Kingdom
facility: Octapharma Research Site
city: London
country: United Kingdom
facility: Octapharma Research Site
city: Plymouth
country: United Kingdom
facility: Octapharma Research Site
city: Stafford
country: United Kingdom
facility: Octapharma Research Site
Study officials:
affiliation: Octapharma
name: Lidia Cosentino
role: STUDY_DIRECTOR
References: