Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIG Clinical Trial
— GAM 10-06Official title:
Non-Interventional Study on the Tolerability and Efficacy of IVIG
| NCT number | NCT02303093 |
| Other study ID # | GAM 10-06 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 1, 2011 |
| Est. completion date | June 5, 2020 |
| Verified date | June 2021 |
| Source | Octapharma |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Non-Interventional Study on the Tolerability and Efficacy of octagam® 10%
| Status | Completed |
| Enrollment | 344 |
| Est. completion date | June 5, 2020 |
| Est. primary completion date | June 5, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Any patient who needs to be treated with a product of this class because of his/her medical condition and whom the treating physician decides to prescribe Octagam or panzyga regularly, may be included. Exclusion Criteria: - None |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Octapharma Research Site | Gmunden | |
| Austria | Octapharma Research Site | Graz | |
| Austria | Octapharma Research Site | Klagenfurt | |
| Austria | Octapharma Research Site | Oberndorf | |
| Austria | Octapharma Research Site | Salzburg | |
| Austria | Octapharma Research Site | Wien | |
| Canada | Hamilton Health Sciences | Hamilton | Ontario |
| Canada | Hospital for Sick Children | Toronto | Ontario |
| Canada | St. Michael's Hospital | Toronto | Ontario |
| Canada | St. Paul's Hospital | Vancouver | British Columbia |
| Canada | Health Sciences Centre | Winnipeg | Manitoba |
| France | Octapharma Research Site | Argenteuil | |
| France | Octapharma Research Site | Béziers | |
| France | Octapharma Research Site | Bourges | |
| France | Octapharma Research Location | Caen | |
| France | Octapharma Research Site | Caen | |
| France | Octapharma Research Site | La Rochelle | |
| France | Octapharma Research Center | Marseille | |
| France | Octapharma Research Location | Marseille | |
| France | Octapharma Research Site | Marseille | |
| France | Octapharma Research Site | Marseille | |
| France | Octapharma Research Site | Montauban | |
| France | Octapharma Research Site | Nantes | |
| France | Octapharma Research Site | Nevers | |
| France | Octapharma Research Site | Pessac | |
| France | Octapharma Research Site | Pierre-Bénite | |
| France | Octapharma Research Site | Rennes | |
| France | Octapharma Research Site | Toulouse | |
| Spain | Octapharma Research Site | Barcelona | |
| Spain | Octapharma Research Location | Madrid | |
| Spain | Octapharma Research Site | Madrid | |
| Spain | Octapharma Research Site | Madrid | |
| Spain | Octapharma Research Site | Madrid | |
| United Kingdom | Octapharma Research Site | Leeds | |
| United Kingdom | Octapharma Research Site | London | |
| United Kingdom | Octapharma Research Site | London | |
| United Kingdom | Octapharma Research Site | Plymouth | |
| United Kingdom | Octapharma Research Site | Stafford |
| Lead Sponsor | Collaborator |
|---|---|
| Octapharma |
Austria, Canada, France, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adverse Drug Reactions | Number of patients with adverse drug reactions | up to one year | |
| Secondary | Infection Occurrence | Pool of PID/SID Patients: Influence of IVIG/SCIG Treatment. Frequency, intensity, and duration of infectious episodes assessed. At the last available assessment, the influence of study IVIG on the frequency, intensity, and duration of the infections. | Up to one year |