Primary Immunodeficiency Disease (PIDD) Clinical Trial
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
| NCT number | NCT02176239 |
| Other study ID # | AHS1-13-003 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 2014 |
| Est. completion date | August 2019 |
| Verified date | August 2019 |
| Source | BriovaRx Infusion Services |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | August 2019 |
| Est. primary completion date | August 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 15 Years to 85 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Atlanta ENT | Atlanta | Georgia |
| United States | IMMUNEOe International Research Centers | Centennial | Colorado |
| United States | AxelaCare Health Solutions, LLC | Lenexa | Kansas |
| United States | Hoag Medical Group (In Alliance with St. Joseph Heritage Healthcare) | Newport Beach | California |
| Lead Sponsor | Collaborator |
|---|---|
| BriovaRx Infusion Services | Bio Products Laboratory (BPL) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Evaluate the profile physician usage (dose and timing) with Gammaplex®. | 1 year | ||
| Secondary | Evaluate physician feedback to having real-time access to 5% treatment naïve IVIg PIDD data captured during home infusions. | 1 year | ||
| Secondary | Evaluate the safety profile of using a 5% treatment naïve IVIg in PIDD patients in the home setting. | 1 year | ||
| Secondary | Demonstration of response rate for those receiving IVIg therapies. | 1 year | ||
| Secondary | Demonstration of changes in outcomes as a result of changes made in IVIg dose and frequency during study participation. | 1 year | ||
| Secondary | Demonstration of measured variables within patients who receive IVIg therapies. | 1 year | ||
| Secondary | Evaluate the effectiveness of whether CareExchange leads to better QOLs and overall patient reported outcomes. | 1 year | ||
| Secondary | Other potential impacts on change in outcomes across patient demographics (age, sex, race, ethnicity, etc.). | 1 year |