Plain English Summary
Background and study aims
Octagam® 5% and Octagam® 10% are solutions that contain human immunoglobulins (antibodies) and are given through the vein (intravenously). They are used for the treatment of congenital or acquired antibody deficiency diseases, immune modulation or in bone marrow transplantation. This study aims to expand our knowledge and experience in the safe use of these medicines.
Who can participate?
Patients who receive treatment with Octagam® 5% or Octagam® 10% can participate in the study.
What does the study involve?
This study does not have any procedures (interventions). Only information about treatment with Octagam® 5% and Octagam® 10% in routine clinical practice will be collected. The treatment with Octagam® 5% and Octagam® 10% will be the same as if they were prescribed outside of the study.
What are the possible benefits and risks of participating?
This is a safety study and all collected information about the observed medicines will make an important scientific contribution in keeping or even improving the high levels of tolerability and safety of Octagam® 5% and Octagam® 10%. These are registered products and the side effects are described in the package insert.
Where is the study run from?
About 150 study centres from all over Germany are participating in this study. Recruitment of participating physicians is still ongoing.
When is the study starting and how long is it expected to run for?
January 2014 to December 2017
Who is funding the study?
Octapharma GmbH (Germany).
Who is the main contact?
Mr Christian Lietz
Non-interventional safety study on the tolerability and safety of Octagam® 5% and Octagam® 10%
Octagam® 5 % and Octagam® 10% are well tolerated in the treatment of primary or secondary immunodeficiencies or in the immunomodulation of autoimmune diseases, in routine clinical use.
An approval by an independent Ethical Committee will be applied for.
Non-interventional prospective multi-centre safety study
Primary study design
Secondary study design
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
As specified in the SPC
Treatment with Octagam® 5% and Octagam® 10% will be documented. This includes data about the patient's disease, age, gender, weight, concomitant medication or illness. For each application, the date and duration of infusion, dose, batch number(s) and the absence or occurrence of an adverse drug reaction (ADR) will be recorded. In case of an ADR, additional detailed information about the reaction will be recorded. If available, laboratory data about the efficacy of treatment should also be documented. No investigations must be initiated for the purpose of this non-interventional trial.
Octagam® 5% and Octagam® 10%
Primary outcome measures
The physician will have to fill out CRFs and send them back in a bunch of six subsequent documented treatments including one form which describes the progress of the treatment over this period. The individual observation period is not limited.
Secondary outcome measures
Quality of life will be evaluated by using the SF-36 health survey
Overall trial start date
Overall trial end date
Participant inclusion criteria
Patients of any age and gender, who receive treatment with Octagam® 5% or Octagam® 10%
Target number of participants
Participant exclusion criteria
Patients with known contraindications as specified in the Summary of Product Characteristics (SPC)
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Octapharma GmbH (Germany)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting