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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 is a clinical trial that was terminated before completion, run by BriovaRx Infusion Services. The registered enrollment target is 1,500 participants.

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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

FieldValue
Enrollment Target 1,500 participants
Start Date 2013-06
Est. Completion 2019-08

Sponsor

BriovaRx Infusion Services

3 total trials

What the Registry Record Tells You About NCT01883921

The ClinicalTrials.gov registry entry for NCT01883921 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 1,500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BriovaRx Infusion Services, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Immunoglobulin Therapy is the first listed.

NCT01883921 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.