NCT01774331

Gamma Globulin Observations and Outcomes Database for Specific Home Infusion Evidence, Patient Care And Research Data (GOOD-SHEPARD)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 11 (actual)
• Sponsor: BriovaRx Infusion Services · Industry
• Sex: All
• Age: 7 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a prospective, observational evaluation of immunoglobulin (Ig) therapy in consenting 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, and standard-of-care outcome measures recorded during normal home infusion visits. Collected data will be de-identified and aggregated into cohorts of like diagnosis for trend analysis.

Conditions

• Intravenous Immunoglobulin (IVIg) Therapy in a Home Infusion Setting

Timeline

• Start date: 2012-11-01
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2013-01-24
• Last updated: 2019-08-07

Locations

1 site across 1 country: United States