Tolerability of the intravenous immunoglobulin Octagam® 10%
| ISRCTN | ISRCTN58800347 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58800347 |
| Protocol serial number | GAM10-05 |
| Sponsor | Octapharma GmbH (Germany) |
| Funder | Octapharma GmbH (Germany) |
- Submission date
- 26/11/2008
- Registration date
- 03/12/2008
- Last edited
- 14/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Anette Debes
Scientific
Scientific
Elisabeth-Selbert-Str. 11
Langenfeld
40764
Germany
| anette.debes@octapharma.de |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Non-interventional prospective multi-centre observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Tolerability of the intravenous immunoglobulin Octagam® 10% |
| Study objectives | Octagam® 10% is well tolerated in routine clinical use in the treatment of primary or secondary immunodeficiencies or in the immunomodulation of autoimmune diseases. |
| Ethics approval(s) | As the procedures during this observational study do not interfere with the patient's usual treatment and monitoring of treatment, this study is not regarded as a clinical study as defined by EU Directive 2001/20/EC. Therefore, approval by an Independent Ethical Committee is not required. |
| Health condition(s) or problem(s) studied | Primary or secondary immunodeficiencies, immunomodulation in autoimmune diseases |
| Intervention | Treatment with 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. The number of treatments with Octagam® 10% for each patient cannot be defined due to the different indications where it is used. Therefore some patients will be treated and observed for a few weeks and others for several months or years. For this reason, there are no specified timepoints for the outcomes of this trial. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Octagam® 10% |
| Primary outcome measure(s) |
To observe the tolerability of Octagam® 10% in different indication groups in routine clinical practice |
| Key secondary outcome measure(s) |
Data about the efficacy of Octagam® 10% |
| Completion date | 14/09/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | All |
| Target sample size at registration | 600 |
| Key inclusion criteria | Patients of any age and gender who receive treatment with Octagam® 10% |
| Key exclusion criteria | Patients with known contraindications to Octagam® 10% |
| Date of first enrolment | 15/09/2008 |
| Date of final enrolment | 14/09/2013 |
Locations
Countries of recruitment
- Germany
Study participating centre
Octapharma GmbH
Langenfeld
40764
Germany
40764
Germany
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.
