The tolerability of Octagam® 5% and Octagam® 10%
| ISRCTN | ISRCTN02245668 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02245668 |
| Protocol serial number | GAM10-06 |
| Sponsor | Octapharma AG (Switzerland) |
| Funder | Octapharma AG (Switzerland) |
- Submission date
- 01/09/2011
- Registration date
- 25/10/2011
- Last edited
- 14/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Plain English summary of protocol
Background and study aims?
Several kinds of illnesses (autoimmune diseases and immune deficient conditions) are treated with Octagam. Octagam is a solution that contains human antibodies, also called immunoglobulins. In this study the data about the treatment with Octagam will be collected to analyse how often and which side effects might occur when treated with Octagam in regular praxis as prescribed by your doctor.
Who can participate?
Only the doctor can decide which disease can be treated with Octagam. People of any age and any gender are welcome to participate.
What does the study involve?
The study collects only data and therefore the doctor might ask you some questions regarding previous diseases or treatments. There will be no special investigations or procedures due to the study. The treatment with Octagam will be regular as prescribed by your doctor without the study.
What are the possible benefits and risks of participating?
All information collected in the course of the treatment with Octagam may make an important scientific contribution, in particular to other patients suffering from the same or similar conditions that may also be treated with Octagam. Octagam is a registered product, the side effects are described in the package insert.
Where is the study run from?
About 1000 patients will participate in this study, which will be performed in several countries around the world (e.g. Austria, France, UK, Brazil, and other). In the USA there will be a related study.
When is study starting and how long is it expected to run for?
The study is planned to start in September 2011. The overall study duration will be approximately 3 years.
Who is funding the study?
A Swiss company called Octapharma, who is producing Octagam, is organising and funding this study.
Who is the main contact?
Dr Daniel Svorc and Dr Stefan Wietek
daniel.svorc@octapharma.com
Contact information
Scientific
Auenbruggerplatz 22
Graz
8036
Austria
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective uncontrolled multi-centre multi-national non-interventional study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | A non-interventional study on the tolerability of Octagam® 5% and Octagam® 10% |
| Study acronym | GammaTrack |
| Study objectives | Re-establish the tolerability profile of Octagam® seen over the last 15 years before the suspension of the marketing authorisations for Octagam® (human normal immunoglobulin 5% and 10%) by the European Medicines Agency. |
| Ethics approval(s) | Ethics Committee of Medical University Graz, Austria, 25/07/2011 ref: 23-474 ex 10/11 |
| Health condition(s) or problem(s) studied | Any indication, age, or treatment regimen in which Octagam is prescribed |
| Intervention | The individual observation period for one patient is not limited, PID patients should be observed for a minimum of 10 months, if possible. |
| Intervention type | Other |
| Primary outcome measure(s) |
Incidence of adverse drug reactions (ADRs) |
| Key secondary outcome measure(s) |
Efficacy of treatment |
| Completion date | 01/06/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 1000 |
| Key inclusion criteria | All patients treated with Octagam at a participitating site. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/09/2011 |
| Date of final enrolment | 01/06/2014 |
Locations
Countries of recruitment
- United Kingdom
- Austria
- Brazil
- France
- Russian Federation
Study participating centre
8036
Austria
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | post-authorisation safety analysis | 01/05/2018 | Yes | No | |
| Results article | 08/03/2018 | 14/11/2022 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/11/2022: Publication reference added.
19/10/2017: Publication reference added.
