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

NCT02176239 | Completed

• 1 other identifier: AHS1-13-003
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Primary Immunodeficiency Disease (PIDD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (1)

Gammaplex® IVIg

Eligibility Criteria

• Age: 15 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Diagnosis of any form of Primary Immunodeficiency Disease
• Males and Females
• ≥ 15 and ≤ 85 years of age
• % 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.

Sponsors & Collaborators

• BriovaRx Infusion Services: lead
• Bio Products Laboratory (BPL): collaborator

Study Sites (4)

Hoag Medical Group (In Alliance with St. Joseph Heritage Healthcare)

Newport Beach, California, 92663, United States

Location

IMMUNEOe International Research Centers

Centennial, Colorado, 80122, United States

Location

Atlanta ENT

Atlanta, Georgia, 30342, United States

Location

AxelaCare Health Solutions, LLC

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 27, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: August 7, 2019

Record last verified: 2019-08

Locations

US (4)