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NCT00322556 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
A Phase 3 study, sponsored by CSL Behring.
- Completed
- Registry status
- Phase 3
- Development phase
- 55
- Enrollment target
NCT00322556 is a Phase 3 study that has completed, run by CSL Behring. The registered enrollment target is 55 participants.
The verdict
NCT00322556, a Phase 3 study, has completed, sponsored by CSL Behring.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 55 participants
- Enrollment target
Study Summary
The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety, the number of infusions temporally associated with AEs, the rate, severity and relationship of all AEs and the vital sign changes during each infusion will be evaluated.
Interventions
- DRUG Immunoglobulins Intravenous (Human)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2005-11 |
| Est. Completion | 2008-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00322556
The ClinicalTrials.gov registry entry for NCT00322556 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CSL Behring, which has 71 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Immunoglobulins Intravenous (Human) is the first listed.
NCT00322556 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00322556 about?
NCT00322556 is a clinical study titled "Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)". The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety, the number of infusions temporally associated with AEs, the rate, severity and relationship of all AEs and the vit...
What is the current status of trial NCT00322556?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 55 participants. The study started on 2005-11. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00322556?
The interventions under investigation include: Immunoglobulins Intravenous (Human) (DRUG).
Who is sponsoring clinical trial NCT00322556?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
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