Tolerability and safety of octagam® 5%, octagam® 10% and panzyga®
| ISRCTN | ISRCTN68324970 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68324970 |
| Secondary identifying numbers | GAM-33 |
- Submission date
- 15/11/2013
- Registration date
- 19/11/2013
- Last edited
- 19/11/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Plain English Summary
Background and study aims
octagam® 5%, octagam® 10% and panzyga® are solutions that contain human immunoglobulins (antibodies) and are given through the vein (intravenously). They are used for the treatment of congenital or acquired antibody deficiency diseases, immune modulation or in bone marrow transplantation. This study aims to expand our knowledge and experience in the safe use of these medicines.
Who can participate?
Patients who receive treatment with octagam® 5%, octagam® 10% or panzyga®.
What does the study involve?
This study does not have any procedures (interventions). Only information about treatment with octagam® 5%, octagam® 10% or panzyga® in routine clinical practice is collected. The treatment with octagam® 5%, octagam® 10% or panzyga® is the same as if they were prescribed outside of the study.
What are the possible benefits and risks of participating?
This is a safety study and all collected information about the observed medicines will make an important scientific contribution in keeping or even improving the high levels of tolerability and safety of octagam® 5%, octagam® 10% or panzyga®. These are registered products and the side effects are described in the package insert.
Where is the study run from?
About 200 study centres from all over Germany are participating in this study. Recruitment of participating physicians is still ongoing.
When is the study starting and how long is it expected to run for?
January 2014 to December 2019
Who is funding the study?
Octapharma GmbH (Germany).
Who is the main contact?
Mr Christian Lietz
christian.lietz@octapharma.de
Contact information
Scientific
Elisabeth-Selbert-Strasse 11
Langenfeld
40764
Germany
Study information
| Study design | Non-interventional prospective multi-centre safety study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Multi-centre |
| 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 | Non-interventional safety study on the tolerability and safety of octagam® 5%, octagam® 10% and panzyga® |
| Study hypothesis | octagam® 5%, octagam® 10% or panzyga® are well tolerated in the treatment of primary or secondary immunodeficiencies or in the immunomodulation of autoimmune diseases, in routine clinical use. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Autoimmune diseases |
| Intervention | Treatment with octagam® 5%, octagam® 10% or panzyga® 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 1. octagam® 5% 2. octagam® 10% 3. panzyga® |
| Primary outcome measure | The physician will have to fill out CRFs and send them back in a bunch of six subsequent documented treatments including one form which describes the progress of the treatment over this period. The individual observation period is not limited. |
| Secondary outcome measures | Quality of life will be evaluated by using the SF-36 health survey |
| Overall study start date | 01/01/2014 |
| Overall study end date | 31/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 5000 |
| Participant inclusion criteria | Patients of any age and gender, who receive treatment with octagam® 5%, octagam® 10% or panzyga® |
| Participant exclusion criteria | Patients with known contraindications as specified in the Summary of Product Characteristics (SPC) |
| Recruitment start date | 01/02/2014 |
| Recruitment end date | 30/11/2019 |
Locations
Countries of recruitment
- Germany
Study participating centre
40764
Germany
Sponsor information
Industry
Elisabeth-Selbert-Strasse 11
Langenfeld
40764
Germany
"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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2016 | Yes | No |
Editorial Notes
19/11/2018: Publication reference added.
07/02/2017: The recruitment dates have been updated from 01/01/2014 - 31/12/2017 to 01/02/2014 - 30/11/2019.
25/01/2017: In 2017, a new investigational product “panzyga®” has been integrated into the study. The study record has been updated to include this product, as well as the following changes:
1. The target number of participants has been updated from 2000 to 5000
2. The overall trial end date has been updated from 31/12/2017 to 31/12/2019
06/02/2016: The overall trial end date was changed from 31/12/2015 to 31/12/2017.
