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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
GAMr-29
Study information
Scientific title
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
Acronym
GAMr 29
Study hypothesis
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.
Ethics approval
Polish Ministry of Health, 24 September 2012 ref: MZOKB-078-262-1/EO
Study design
Prospective open-label non-controlled multicenter phase III study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Primary Immunodeficiency diseases (PID)
Intervention
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.
Intervention type
Other
Phase
Phase III
Drug names
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
3. AEs
4. Laboratory parameters
Overall trial start date
15/07/2012
Overall trial end date
15/07/2013
Reason abandoned
Eligibility
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
23
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
15/07/2012
Recruitment end date
15/07/2013
Locations
Countries of recruitment
Czech Republic
Trial participating centre
Octapharma
Vienna
1100
Austria
Sponsor information
Organisation
Octapharma (Switzerland)
Sponsor details
Oberlaaerstrasse 235
Vienna
1100
Austria
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Octapharma AG (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Publication summary