Trial document




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  DRKS00016556

Trial Description

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Title

Non-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

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Trial Acronym

KBOs009

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URL of the Trial

http://-

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Brief Summary in Lay Language

The study concerns patients with infections due to immune deficiency caused by malignant blood disease, who are receiving immunoglobulin Ig Vena treatment. The goal of this study is to evaluate the treatment with Ig Vena. Furthermore, the goal is to determine the safety and tolerability of Ig Vena. Information will be collected throughout routine tests.

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Brief Summary in Scientific Language

Non-interventional, open, multicenter, prospective cohort study to collect available data from everyday clinical practice at sites where patients with SID are regularly treated with Ig Vena.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00016556
  •   2019/02/01
  •   [---]*
  •   no
  •   Approved
  •   Bo/42/2018, Ethikkommission bei der Ärztekammer Niedersachsen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   D84.9 -  Immunodeficiency, unspecified
  •   C90.0 -  Multiple myeloma
  •   C91.1 -  Chronic lymphocytic leukaemia of B-cell type
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Interventions/Observational Groups

  •   Patients with secondary immunodeficiency (SID) and recurrent bacterial infections due to two malignant hematologic diseases (MM and CLL) will be asked if they would like to participate in this observational study. Patients may be included in the study if they are planned to receive at least one Ig-Vena infusion. The attending physician will be asked to enter data collected during routine visits into an electronic case report form (eCRF). These data will be analysed.
    The observation time corresponds to the duration of treatment with Ig Vena. The minimum observation time is 1 month.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   IV
  •   No
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Primary Outcome

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.

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Secondary Outcome

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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
  • Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Medical Center 
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Recruitment

  •   Actual
  •   2019/02/07
  •   200
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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.

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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.

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Addresses

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    • Kedrion S.p.A.
    • Castelvecchio Pascoli
    • 55051   Barga (Lucca)
    • Italy
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Lukas-Krankenhaus
    • Mr.  Prof. Dr.  Markus  Ruhnke 
    • Hindenburgstraße 56
    • 32257  Bünde
    • Germany
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    • Kedrion S.p.A.
    • Mr.  Ivan  Marjanovic 
    • Castelvecchio Pascoli
    • 55051   Barga (Lucca)
    • Italy
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Sources of Monetary or Material Support

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    • Kedrion S.p.A.
    • Castelvecchio Pascoli
    • 55051  Barga (Lucca)
    • Italy
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  •   Study Protocol
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* This entry means the parameter is not applicable or has not been set.