NCT01883921

Gamma Globulin Observations and Outcomes Database for Patients With Primary Immunodeficiency Disease (GOOD-SHEPARD-PI)

Gamma Globulin Observations and Outcomes Database for Specific Home Infusion Evidence, Patient Care And Research Data in Patients With Primary Immunodeficiency Disease (GOOD-SHEPARD-PI)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: BriovaRx Infusion Services · Industry
• Sex: All
• Age: 7 Years
• Healthy volunteers: Not accepted

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 disability assessments in patients with Primary Immunodeficiency Disease (PIDD). Secondary: * Change in Intravenous/Subcutaneous Immunoglobulin (IVIg/SCIg) dose effects measured outcomes. * Change in IVIg/SCIg dose timing effects measured outcomes. * Change in patient status is reflected in measured outcomes. * Assess the value to physicians from collected outcomes data. * Identify types of patients by response to IVIg/SCIg therapies (well maintained, problematic, etc.). * Change in response rate as measured by outcomes to IVIg/SCIg therapies by disease state, co-morbidities, and demographics.

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 (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.

Conditions

• Primary Immune Deficiency Disorder

Interventions

Type	Name	Description
OTHER	Immunoglobulin Therapy

Timeline

• Start date: 2013-06-01
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2013-06-21
• Last updated: 2019-08-07

Locations

1 site across 1 country: United States