A Study to Evaluate the Benefit of RUCONEST in Subjects Who Experience ADRs Related to IVIG Infusions

  • STATUS
    Recruiting
  • participants needed
    20
  • sponsor
    IMMUNOe Research Centers
Updated on 16 August 2022
immunodeficiency
immunoglobulins
igiv
immune globulin

Summary

Patients receiving intravenous immunoglobulin (IVIG) therapy for primary immunodeficiency and neurologic conditions may experience adverse drug reactions (ADRs). The mechanism of the ADR is unknown. Currently, the standard practice for these patients is to change from IV to subcutaneous IG (SCIG) but because of the need of immunomodulation or patient preference, SCIG may not be an option. Data has shown that some levels of complement decrease from preto post-infusion of IVIG. This study is to determine if replacing this complement protein may ameliorate ADRs.

Description

This is a single-site, pilot study conducted in the US to determine the benefit of human C1-esterase inhibitor [recombinant] (C1-INH-R) therapy to ameliorate ADRs in subjects receiving IVIG therapy experience ADRs post-infusion. Subjects who are currently receiving IVIG for immunodeficiency or neurologic conditions and experience ADRs will be enrolled.

In part 1, subjects will continue to receive IVIG for two infusions. Complement proteins will be measured pre- and post-infusion. Quality of life and other questionnaires will be administered.

In part 2, subjects will receive C1-INH-R infusion prior to receiving IVIG infusion for three infusions. Complement proteins will be measured pre- and post- infusion. Quality of life and other questionnaires will be administered.

Details
Condition Common Variable Immunodeficiency, Common Variable Immunodeficiency (CVID), Common Variable Immunodeficiency (CVID)
Treatment C1-esterase inhibitor [recombinant] (C1-INH-R)
Clinical Study IdentifierNCT03576469
SponsorIMMUNOe Research Centers
Last Modified on16 August 2022

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