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

NCT01774331 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 11

Last updated 2019-08-07

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • BriovaRx Infusion Services

    lead INDUSTRY

Principal Investigators

  • Jeffrey A. Allen, MD · Northwestern University and University of Minnesota

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2019-08-31
Completion
2019-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01774331 on ClinicalTrials.gov