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

Primary Immune Deficiency Disorder Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01883921
• Other study ID #: BIS1-13-002
• Status: Terminated
• Start date: June 2013
• Est. completion date: August 2019

Study information

• Verified date: August 2019
• Source: BriovaRx Infusion Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1500
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Primary Immune Deficiency Disorder

Intervention

Other:
• Immunoglobulin Therapy

Locations

Country	Name	City	State
United States	BriovaRx Infusion Services	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
BriovaRx Infusion Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of collected data captured in CareExchange™ -ability to show and track changes in outcome data in PIDD patients.		Up to 5 Years
Secondary	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.		Up to 5 Years
Secondary	Response rate for those receiving IVIg/SCIg therapies.		Up to 5 Years
Secondary	Exhibit differences in response rate of IVIg/SCIg therapies across disease states and demographics		Up to 5 Years
Secondary	Measure variables within patients who receive IVIg/SCIg therapies		Up to 5 Years