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

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.

Study Overview

• Status: Completed
• Conditions: Primary Immunodeficiency Disease (PIDD)

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Hoag Medical Group (In Alliance with St. Joseph Heritage Healthcare)
  • Colorado
    • Centennial, Colorado, United States, 80122
      • IMMUNEOe International Research Centers
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Atlanta ENT
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • AxelaCare Health Solutions, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Males and Females between 15-85 years of age with any form of PIDD who are considered 5% IVIg treatment naïve and whose physician has decided to prescribe Gammaplex® IVIg therapy.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Gammaplex® IVIg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Analysis of collected data captured in CareExchange will demonstrate the ability to show and track changes in outcome data in 5% treatment naïve IVIg PIDD patients in the home setting.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluate the profile physician usage (dose and timing) with Gammaplex®.	1 year
Evaluate physician feedback to having real-time access to 5% treatment naïve IVIg PIDD data captured during home infusions.	1 year
Evaluate the safety profile of using a 5% treatment naïve IVIg in PIDD patients in the home setting.	1 year
Demonstration of response rate for those receiving IVIg therapies.	1 year
Demonstration of changes in outcomes as a result of changes made in IVIg dose and frequency during study participation.	1 year
Demonstration of measured variables within patients who receive IVIg therapies.	1 year
Evaluate the effectiveness of whether CareExchange leads to better QOLs and overall patient reported outcomes.	1 year
Other potential impacts on change in outcomes across patient demographics (age, sex, race, ethnicity, etc.).	1 year

Collaborators and Investigators

• Sponsor: BriovaRx Infusion Services
• Collaborators: Bio Products Laboratory (BPL)

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: June 24, 2014
• First Submitted That Met QC Criteria: June 26, 2014
• First Posted (Estimate): June 27, 2014

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 6, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Genetic Diseases, Inborn; Immunologic Deficiency Syndromes; Primary Immunodeficiency Diseases
• Other Study ID Numbers: AHS1-13-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No