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NCT01883921 · ClinicalTrials.gov registry record
Gamma Globulin Observations and Outcomes Database for Patients With Primary Immunodeficiency Disease (GOOD-SHEPARD-PI)
A clinical trial, sponsored by BriovaRx Infusion Services.
- Terminated
- Registry status
- 1,500
- Enrollment target
NCT01883921: Clinical Trial study, sponsored by BriovaRx Infusion Services.
NCT01883921 is a clinical trial that was terminated before completion, run by BriovaRx Infusion Services. The registered enrollment target is 1,500 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01883921 was terminated before completion, sponsored by BriovaRx Infusion Services.
- TERMINATED
- Registry status
- 1,500 participants
- Enrollment target
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.
Interventions
- OTHER Immunoglobulin Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,500 participants |
| Start Date | 2013-06 |
| Est. Completion | 2019-08 |
Why NCT01883921 stopped before completion
NCT01883921 is an observational study that tracks outcomes without assigning an intervention. Its 1,500 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which Immunoglobulin Therapy is the first listed.
NCT01883921 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01883921 about?
NCT01883921 is a clinical study titled "Gamma Globulin Observations and Outcomes Database for Patients With Primary Immunodeficiency Disease (GOOD-SHEPARD-PI)". 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: * Chang...
What is the current status of trial NCT01883921?
This trial is currently terminated. The enrollment target is 1,500 participants. The study started on 2013-06. Estimated completion is 2019-08.
What interventions are being tested in trial NCT01883921?
The interventions under investigation include: Immunoglobulin Therapy (OTHER).
Who is sponsoring clinical trial NCT01883921?
This trial is sponsored by BriovaRx Infusion Services, which has 3 total clinical trials registered on ClinicalTrials.gov.
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