An observational study in Primary Immune Deficiency Disorder, sponsored by BriovaRx Infusion Services. Terminated at 1 site in United States. Open to participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2019-08-07.
Sponsored by BriovaRx Infusion Services · Observational
Primary:
Secondary:
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 (formerly AxelaCare Health Solutions, LLC). Subjects meeting all inclusion criteria who have provided informed consent/assent for trial participation will have validated, physician-prescribed, standard-of-care outcome measures, and Ig administration information recorded during normal home infusion visits. There will also be standard-of-care questions captured within some outcome measures recorded during normal home infusion visits that may be at a frequency and/or combination which may not be considered routine clinical care by some physicians who treat for this medical condition. Collected data will be de-identified and aggregated into cohorts of like diagnosis for trend analysis.
199 studies on the registry are indexed under Primary Immunodeficiency Diseases; 46 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 126 across 73 observational studies indexed under Primary Immunodeficiency Diseases.
Browse Primary Immunodeficiency Diseases studies →BriovaRx Infusion Services is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Any patient who is aged 7 years or greater at time of enrollment; who is on Ig therapy, have been on or is between doses of Ig therapy, or is being considered to be prescribed Ig therapy; provides informed consent for participation; and who has been determined to be eligible for infusion services by BriovaRx Infusion Services (formerly AxelaCare Health Solutions, LLC), in collaboration with the patient's prescribing physician. Subjects will be recruited from the practices of participating physicians.
Exclusion Criteria:
Other: Immunoglobulin Therapy
Analysis of collected data captured in CareExchange™ -ability to show and track changes in outcome data in PIDD patients.
Time frame: Up to 5 Years
Physician feedback will demonstrate if having real-time access to patient data captured during a home infusion will assist in the management of the patient's disease.
Time frame: Up to 5 Years
Response rate for those receiving IVIg/SCIg therapies.
Time frame: Up to 5 Years
Exhibit differences in response rate of IVIg/SCIg therapies across disease states and demographics
Time frame: Up to 5 Years
Measure variables within patients who receive IVIg/SCIg therapies
Time frame: Up to 5 Years
This study is terminated, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Primary Immunodeficiency Diseases→
BriovaRx Infusion Services