Clinical trial NCT02176239: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Immunodeficiency Disease (PIDD)
Lead sponsor: BriovaRx Infusion Services
Sponsor class: INDUSTRY
Collaborators: name: Bio Products Laboratory (BPL)
First posted: 2014-06-27
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: Evaluate the profile physician usage (dose and timing) with Gammaplex®.
timeFrame: 1 year
measure: Evaluate physician feedback to having real-time access to 5% treatment naïve IVIg PIDD data captured during home infusions.
timeFrame: 1 year
measure: Evaluate the safety profile of using a 5% treatment naïve IVIg in PIDD patients in the home setting.
timeFrame: 1 year
measure: Demonstration of response rate for those receiving IVIg therapies.
timeFrame: 1 year
measure: Demonstration of changes in outcomes as a result of changes made in IVIg dose and frequency during study participation.
timeFrame: 1 year
measure: Demonstration of measured variables within patients who receive IVIg therapies.
timeFrame: 1 year
measure: Evaluate the effectiveness of whether CareExchange leads to better QOLs and overall patient reported outcomes.
timeFrame: 1 year
measure: Other potential impacts on change in outcomes across patient demographics (age, sex, race, ethnicity, etc.).
timeFrame: 1 year
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Medical Group (In Alliance with St. Joseph Heritage Healthcare)
state: California
city: Centennial
country: United States
facility: IMMUNEOe International Research Centers
state: Colorado
city: Atlanta
country: United States
facility: Atlanta ENT
state: Georgia
city: Lenexa
country: United States
facility: AxelaCare Health Solutions, LLC
state: Kansas
Study officials:
References: