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

Stopped early

Conditions studied: Primary Immune Deficiency Disorder

In brief

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.

Key facts

Study ID

NCT01883921

Run by

BriovaRx Infusion Services

People needed

1500

Starts

2013-06-01

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…

• 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

You may not qualify if…

• 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

Where it is running

• BriovaRx Infusion Services — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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