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

NCT ID: NCT01774331

Last Updated: 2019-08-07

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 11 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2019-08-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Immunoglobulin Therapy

Immunoglobulin Therapy

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BriovaRx Infusion Services

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey A. Allen, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University and University of Minnesota

Locations

AxelaCare Health Solutions, LLC

Lenexa, Kansas, United States

Countries

United States

Other Identifiers

AHS1-12-001

Identifier Type: -

Identifier Source: org_study_id