Clinical study to evaluate the efficacy and safety of Octagam 5% in patients with Primary Immunodeficiency diseases (PID)
| ISRCTN | ISRCTN32382999 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32382999 |
| Secondary identifying numbers | GAMr-29 |
- Submission date
- 18/09/2012
- Registration date
- 15/10/2012
- Last edited
- 15/10/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Plain English summary of protocol
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
Contact information
Scientific
Octapharma
Vienna
1100
Austria
Study information
| Study design | Prospective open-label non-controlled multicenter phase III study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | GAMr 29 |
| Study objectives | 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(s) | Polish Ministry of Health, 24 September 2012 ref: MZOKB-078-262-1/EO |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 15/07/2012 |
| Completion date | 15/07/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 23 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/07/2012 |
| Date of final enrolment | 15/07/2013 |
Locations
Countries of recruitment
- Austria
- Czech Republic
Study participating centre
1100
Austria
Sponsor information
Industry
Oberlaaerstrasse 235
Vienna
1100
Austria
| Website | http://www.octapharma.com/ |
|---|---|
"ROR" |
https://ror.org/002k5fe57 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
