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

BriovaRx Infusion Services

Status: Completed

Conditions: Primary Immunodeficiency Disease (PIDD)

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT02176239

AHS1-13-003

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 15 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

20 participants in 1 patient group

Gammaplex® IVIg