Plain English Summary
Background and study aims:
The study will assess if Octagam 5% prevents serious bacterial infections.
Who can participate?
Patients aged between 18 and 75 years with immunodeficiency.
What does the study involve?
The patients will receive an examination at the start of the study and then receive five or six infusions of Octagam 5% over a period of up to 20 weeks. Participants will be asked to give a small amount of blood for assessment .
What are the possible benefits and risks of participating?
Patients health condition will be assessed very thoroughly and in shorter intervals than normal. There are no known risks of participating.
Where is the study run from?
Octapharma AG in Switzerland a pharmaceutical company producing and selling products developed from blood plasma.
When is study starting and how long is it expected to run for?
Study is starting in June 2012 and expected end is in October 2013
Who is funding the study?
Octapharma AG, Switzerland
Who is the main contact?
Dr Eva Turpel-Kantor
Prospective, open-label, non-controlled, multicenter, phase III clinical study to evaluate the pharmacokinetics, safety and efficacy of Octagam 5% in patients with Primary Immunodeficiency Diseases
The pharmacokinetic of Octagam 5% ("double-processed" Octagam) and efficacy in preventing serious bacterial infections is as to be expected for a compound of this class.
Polish Ministry of Health, 24 September 2012 ref: MZOKB-078-262-1/EO
Prospective open-label non-controlled multicenter phase III study
Primary study design
Secondary study design
Non randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Primary Immunodeficiency diseases (PID)
Two multiple dose intravenous Octagam 5% regimens (every 3 weeks or every 4 weeks, continuing the patients pre-study infusion interval) for 6 or 5 Octagam infusions for patients on a 3-week or 4-week schedule, respectively .
The investigational medicinal product (IMP) name is Octagam 5%, a human immunoglobulin (Ig) solution with 5% protein content for intravenous administration.
Primary outcome measures
The primary endpoint is the PK profile of Octagam with respect to total IgG, IgG subclasses
Secondary outcome measures
The following parameters will be used in the safety and tolerability assessment of the treatment:
1. Vital signs
2. Physical examination
4. Laboratory parameters
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Age between 18 years and 75 years
2. Primary immunodeficiency syndromes with significant component hypogamma-globulinaemia or antibody deficiency
3. Previously treated with a commercial IVIG every 2128 days for at least 6 infusion intervals at a constant dose between 200 and 800 mg/kg body weight
4. Availability of the IgG trough levels of the 2 previous infusions before enrolment
Target number of participants
Participant exclusion criteria
1. Acute infection
2. Known history of adverse reactions to IgA in other products
3. Exposure to blood or any blood product, other than commercially available IVIG, within the past 3 months prior to enrolment
4. Congestive heart failure NYHA class III or IV
5. Non-controlled arterial hypertension
6. History of deep vein thrombosis
7. Known HIV, HCV, or HBV infection
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Octapharma AG (Switzerland)
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