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

NCT01883921 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2019-08-07

No results posted yet for this study

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.

Conditions

  • Primary Immune Deficiency Disorder

Interventions

OTHER

Immunoglobulin Therapy

Sponsors & Collaborators

  • BriovaRx Infusion Services

    lead INDUSTRY

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
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 NCT01883921 on ClinicalTrials.gov