DRKS00016556
Active, not recruiting
Not Applicable
on-interventional study on management of treatment and safety in patients with secondary immunodeficiency due to haematological malignancies treated with Ig Vena according to the approved therapeutic indications - KBOs009
Kedrion S.p.A.0 sites25 target enrollmentFebruary 1, 2019
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- D84.9
- Sponsor
- Kedrion S.p.A.
- Enrollment
- 25
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \>18 years.
- •\- SID patients with recurrent bacterial infections due to haematological malignancies according to the approved therapeutic indications as per Ig Vena SmPC (as are primary immunodeficiency syndromes with impaired antibody production, hypogammaglobulinaemia and recurrent bacterial infections \[in patients with CLL in whom prophylactic antibiotics have failed; or plateau phase MM patients who have failed to respond to pneumococcal immunization; or patients after allogeneic haematopoietic stem cell transplantation; or congenital AIDS with recurrent bacterial infections]; or patients with primary immune thrombocytopenia, at high risk of bleeding or prior to surgery to correct platelet count; Guillain Barré syndrome; chronic inflammatory demyelinating polyradiculoneuropathy; Kawasaki disease), naïve to IgG or pre\-treated with IgG.
- •\- Patients were prescribed treatment with Ig Vena as part of the clinical routine, independent of and prior to the decision to enroll patients in the study.
- •\- Patient information and consent form was signed by the patient.
Exclusion Criteria
- •\- A history of severe or serious reactions to or hypersensitivity to IVIg or other forms of IgG administered by injection, or to any of the components.
- •\- Patients with IgA deficiency and documented antibodies to IgA.
- •\- At the discretion of the attending physician, based on specific warnings and precautions for use, which are described in the Ig Vena Specialist Information and from clinical routine.
Outcomes
Primary Outcomes
Not specified
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