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

• Conditions: D84.9; C90.0; C91.1; Immunodeficiency, unspecified; Multiple myeloma; Chronic lymphocytic leukaemia of B-cell type

• Registration Number: DRKS00016556
• Lead Sponsor: Kedrion S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Study Completion: 2020-12-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary evaluation of the treatment management with Ig Vena will be based on the prospectively obtained administration data of the MP throughout the non-interventional study, focussing on times, dosages, tolerability and safety of the treatment cycles. In addition the capability of the MP treatment to prevent serious bacterial infection episodes will be studied through comparison with patient’s pre-study data.<br><br>

Secondary Outcome Measures

Name	Time	Method
Secondly, medical indications for start, stop or interruption of Ig Vena treatment will be assessed by evaluating investigator reasons for initiation and cessation of IVIG therapy and the historic details of the primary diseases.