Status:
TERMINATED
Gamma Globulin Observations and Outcomes Database for Patients With Primary Immunodeficiency Disease (GOOD-SHEPARD-PI)
Lead Sponsor:
BriovaRx Infusion Services
Conditions:
Primary Immune Deficiency Disorder
Eligibility:
All Genders
7+ years
Brief Summary
Primary: * Demonstrate the utility of an electronic data capture (EDC) system (CareExchange™) using infusion nurse and patient measured physical, quality of life (QOL), respiratory, laboratory, and d...
Detailed Description
This is a prospective, observational evaluation of immunoglobulin (Ig) therapy in consenting PIDD adult and assenting pediatric subjects who receive infusion services from BriovaRx Infusion Services (...
Eligibility Criteria
Inclusion
- Diagnosis of any form of Primary Immunodeficiency Disease
- Age at enrollment ≥ 7
- Sign informed consent/assented to participation
- Ability to read and write English
- Understanding of study procedures and ability to comply with study procedures for the entire length of the study
- Receiving Ig under the discretion of the patient's treating physician in accordance with standard treatment practices
- Have been on or is between doses of Ig under the discretion of the patient's treating physician in accordance with standard treatment practices
- Being considered to be prescribed Ig under the discretion of the patient's treating physician in accordance with standard treatment practices
- Determined to be eligible for infusion services by BriovaRx Infusion Services (formerly AxelaCare Health Solutions, LLC.) in collaboration with the patient's prescribing physician
Exclusion
- Children (age ≤ 6 years)
- Prisoners, and other wards of the state
- Determined to have non-competency of data collection requirements (physical assessments and use of an iPAD™) by the study participant's caregiver
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2019
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT01883921
Start Date
June 1 2013
End Date
August 1 2019
Last Update
August 7 2019
Active Locations (1)
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1
BriovaRx Infusion Services
Lenexa, Kansas, United States, 66219