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

Intravenous Immunoglobulin (IVIg) Therapy in a Home Infusion Setting Clinical Trial

— GOOD-SHEPARD  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01774331
• Other study ID #: AHS1-12-001
• Status: Terminated
• Start date: November 2012
• 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• 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:

• 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

Exclusion Criteria:

• Children (age = 6 years)

• Prisoners, and other wards of the state

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	AxelaCare Health Solutions, LLC	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
Other	Demonstration of response rate for those receiving IVIg.		5 Years
Other	Exhibit differences in response rate of IVIg therapy across disease states and demographics.		5 Years
Other	Demonstration of measured variables within patients who receive IVIg.		5 Years
Primary	Analysis of collected data captured in CareExchange™ will demonstrate the ability to show and track changes in outcome data.		5 Years
Secondary	Physician feedback will demonstrate that having real-time access to patient data captured during a home infusion will assist in the management of the patient's disease.		5 Years