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Completed

NCT Number: NCT02303093

Non-Interventional Study on the Tolerability and Efficacy of IVIG

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

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Octapharma Research Site, Gmunden, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Octagam IVIG 5% or 10%

Biological

Octagam IVIG 5% or 10%

Panzyga

Biological

Panzyga

Primary outcomes

  1. Adverse Drug Reactions

    Time frame: up to one year

    Number of patients with adverse drug reactions

Secondary outcomes

  1. Infection Occurrence

    Time frame: Up to one year

    Pool of PID/SID Patients: Influence of IVIG/SCIG Treatment. Frequency, intensity, and duration of infectious episodes assessed. At the last available assessment, the influence of study IVIG on the frequency, intensity, and duration of the infections.

Sponsors and collaborators

Lead sponsor

Octapharma

Industry

Registry information

Acronym: GAM 10-06

Important dates

Study start
2011
Primary completion
2020
Study completion
2020
First posted
Nov 27, 2014
Registry last updated
Jun 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.