Non-Interventional Study on the Tolerability and Efficacy of IVIG (GAM 10-06)

Octapharma

Status: Completed

Conditions: Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIG

Treatments: Biological: Panzyga; Biological: Octagam IVIG 5% or 10%

Study type: Observational

Funder types: Industry

Identifiers

NCT02303093

GAM 10-06

Details and patient eligibility

About

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

Full 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.

Enrollment: 344 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

344 participants in 2 patient groups

Octagam

Description:

Patient receiving Octagam 5% or 10% IVIG

Treatment:

Biological: Octagam IVIG 5% or 10%

Panzyga

Description:

Patient receiving panzyga

Treatment:

Biological: Panzyga