Gamma Globulin Observations and Outcomes Database for Specific Home Infusion Evidence, Patient Care And Research Data (GOOD-SHEPARD)
Stopped early
Conditions studied: Intravenous Immunoglobulin (IVIg) Therapy in a Home Infusion Setting
In brief
Primary: • Demonstrate the utility of a new electronic data capture (EDC) system (CareExchange™) using infusion nurse measured physical, quality of life (QOL), respiratory, and disability assessments. Secondary: * Change in Intravenous Immunoglobulin (IVIg) dose effects measured outcomes. * Change in IVIg dose and timing effects measured outcomes. * Change in patient status is reflected in measured outcomes. * Assess the value to physicians from infusion nurse collected outcomes data. * Identify types of patients by response to IVIg therapy (i.e. natural or poor responders). * Change in response rate to IVIg therapy by disease state and demographics.
Key facts
- Study ID
- NCT01774331
- Run by
- BriovaRx Infusion Services
- People needed
- 11
- Starts
- 2012-11-01
- Expected to finish
- 2019-08-01
- Last updated by the study team
- 2019-08-07
Who can join
Age: 7 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 IVIg under the discretion of the patient's treating physician in accordance with standard treatment practices
- Have been on or is between doses of IVIg under the discretion of the patient's treating physician in accordance with standard treatment practices
- Being considered to be prescribed IVIg under the discretion of the patient's treating physician in accordance with standard treatment practices
- Determined to be clinically eligible for infusion services by BriovaRx Infusion Services (Formerly AxelaCare Health Solutions, LLC.) in collaboration with the patient's prescribing physician
You may not qualify if…
- Children (age ≤ 6 years)
- Prisoners, and other wards of the state
Where it is running
- AxelaCare Health Solutions, LLC — Lenexa, Kansas, United States
Full record on ClinicalTrials.gov
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