Monitoring of 5% Treatment Naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) Patients Using the CareExchange® System: A Pilot Study Using 5% Gammaplex® IVIg in the Home Setting

Completed

Conditions studied: Primary Immunodeficiency Disease (PIDD)

In brief

The purpose of this study is to demonstrate the utility of measuring outcomes in 5% treatment naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) patients using infusion nurse and patient measured physical, quality of life (QOL), respiratory, and disability assessments using CareExchange in the home setting.

Key facts

Study ID

NCT02176239

Run by

BriovaRx Infusion Services

People needed

20

Starts

2014-06-01

Expected to finish

2019-08-01

Last updated by the study team

2019-08-07

Who can join

Age: 15 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of any form of Primary Immunodeficiency Disease
• Males and Females
• ≥ 15 and ≤ 85 years of age
• 5% treatment Naïve IVIg for the treatment of PIDD
• Ability to have Gammaplex® IVIg prescribed under the discretion of the patient's treating physician in accordance with standard treatment practices for the entire duration of the study
• Ability and willingness to provide informed consent and comply with study requirements and procedures
• Ability to read and write English
• Understanding of study procedures and ability to comply with study procedures for the entire length of the study
• Eligible for infusion services by AxelaCare Health Solutions, LLC, in collaboration with the subject's prescribing physician and insurance provider

You may not qualify if…

• The presence of any medical condition that the investigator and/or prescribing physician deems incompatible with participation in this trial.
• Prisoners, and other wards of the state
• Determined to have non-competency of data collection requirements (physical assessments and use of an iPAD™) by either the home infusion nurse and/or Caregiver.
• Receiving Subcutaneous Immunoglobulin (SCIg) Therapy during study participation.

Where it is running

• Hoag Medical Group (In Alliance with St. Joseph Heritage Healthcare) — Newport Beach, California, United States
• IMMUNEOe International Research Centers — Centennial, Colorado, United States
• Atlanta ENT — Atlanta, Georgia, United States
• AxelaCare Health Solutions, LLC — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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