Investigator-Initiated Studies

In order to advance science and improve patient care with CSL Behring's products in the area of immunoglobulin research, we support, with total or partial funding, high-quality research that is initiated, designed, implemented, and sponsored by external investigators.  Support is provided based on the scientific merit of the proposal as well as alignment with the following specific areas of interest:

Primary Immunodeficiency (PID)
Proposals that increase the knowledge of the efficacy and safety of the immunoglobulins in PID indications, specifically route of administration, subclinical infections in diagnosed PID patients with respiratory tract engagement, quality of life, wear-off, manual push, flexible dosing/patient preference, and undiagnosed PID.

Secondary Immune Deficiency (SID)
Proposals that increase the knowledge of immunoglobulins in regard to efficacy and safety, specifically the combination of immunoglobulins with products that cause drug-induced SID in conditions such as multiple myeloma and chronic lymphocytic leukemia (CLL).

Peripheral Neuropathy
Proposals that increase the knowledge of efficacy and safety of the and pediatric patients.

_{Hizentra and Privigen are manufactured by CSL Behring AG and distributed by CSL Behring LLC.
Hizentra® and Privigen® are registered trademarks of CSL Behring AG.}

To advance science and improve patient care with CSL Behring's products, we support, through total or partial funding, external investigators who initiate, design and implement high-quality research that is focused on our recombinant products, IDELVION® (Coagulation Factor IX (Recombinant) Albumin Fusion Protein) and AFSTYLA® (Antihemophilic Factor (Recombinant) Single Chain). Support is provided based on the scientific merit of the proposal as well as alignment with the following specific areas of interest:

Haemophilia A and B

• Clinical studies and experience in transitioning to AFSTYLA® or IDELVION®, including on-demand and prophylaxis
• Health outcome studies, including factor consumption, quality of life data, adherence
• Health economic outcome studies
• Clinical studies that focus on long-term joint health and radiographic imaging to assess and monitor joint damage
• Use in special populations including women
• Real-world evidence of hemophilia A and B management

• Role of von Willebrand Factor (VWF) in reducing inhibitor development
• Clinical studies that increase knowledge of immune tolerance induction with AFSTYLA®

In order to advance science and improve patient care with CSL Behring's products in the areas of oral anticoagulant-associated bleeding, acquired bleeding disorders, and hereditary angioedema we support, through the provision of drug and/or total/partial funding, high-quality research that is initiated, designed, implemented and sponsored by external investigators. Support is provided based on the scientific merit of the proposal as well as alignment with the following specific areas of interest:

Oral Anticoagulant-Associated Bleeding

• Clinical studies and experience with prothrombin complex concentrates (PCCs) for the management of acute major bleeding in patients treated with Vitamin K antagonists (VKAs) or novel oral anticoagulants (NOACs)
• Clinical studies and experience with PCCs for urgent reversal prior to emergency surgery or procedures in patients treated with VKAs or NOACs

• Clinical studies of PCCs as a haemostatic agent in perioperative bleeding and trauma-induced coagulopathy
• Basic science research with PCCs in trauma-induced coagulopathy

• Health Outcome studies on C1 Esterase Inhibitor (C1-INH) including quality of life and adherence
• Clinical studies and experience with novel treatment strategies to replace C1-INH
• Use of C1-INH in special patient populations (eg pregnancy, paediatrics)

A: You can contact your regional Medical Science Liaison by clicking here.

A: You should submit a full proposal of the study for CSL Behring to consider for review. Conceptual or high-level proposals will not be considered until they are fully developed.

A: Full submissions are reviewed on a monthly basis and you will be notified when the CSL Behring Review Committee has arrived at a decision. Decisions are based on medical and scientific value in addition to current resources and research priorities.

A: CSL Behring is considered the Grant Provider for any Investigator-Initiated Study that it funds. Due to certain legal implications, the role of Sponsor needs to be assumed by either the Investigator or the Investigator’s Organization.