US Clinical Trial NCT03576469

A Single-site, Open-Label, Pilot Study to Evaluate the Benefit of RUCONEST® in Subjects With CVID Who Experience ADRs Related to IVIG Infusions  Nov 21, 2018

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 for CVID for experience ADRs post-infusion. CVID subjects who are currently receiving IVIG every 3 to 4 weeks for immunodeficiency 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.

Parties

Contacts
Investigators
Sponsors
Countries
US
Keywords
Adverse drug reaction (ADR) C1-esterase inhibitor CVI - Common Variable Immunodeficiency Intravenous Immunoglobulin

Similar records

Title

Source:  NIH Last updated:  Nov 21, 2018

From ClinicalTrials.gov, a database of the U.S. National Institutes of Health, through its National Library of Medicine. This record may not reflect the most current and accurate biomedical/scientific data available from the NLM/NIH.