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NCT00419341 · ClinicalTrials.gov registry record · Phase 3
Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy
A Phase 3 study of Primary Immune Deficiency, sponsored by CSL Behring.
- Completed
- Registry status
- Phase 3
- Development phase
- 49
- Enrollment target
- 13
- Study locations
NCT00419341: Completed Phase 3 study of Primary Immune Deficiency, sponsored by CSL Behring.
NCT00419341 is a Phase 3 study of Primary Immune Deficiency that has completed, run by CSL Behring. The registered enrollment target is 49 participants, below the 1,195-participant average among 5 other Primary Immune Deficiency trials with a reported enrollment target (96% lower). The trial reports 13 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00419341, a Phase 3 study of Primary Immune Deficiency, has completed, sponsored by CSL Behring.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 49 participants
- Enrollment target
- 13
- Study locations
Study Summary
The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).
Primary Outcome
The annualized rate was based on the total number of SBIs and the total number of subject study days during the efficacy period for all subjects in the specified analysis population and adjusted to 365 days. Potential SBIs included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an adverse event (AE) was identified as a potential SBI, the AE was adjudicated by a review committee to determine if the event fulfilled the predefined c
Conditions Studied
Interventions
- BIOLOGICAL Human Normal Immunoglobulin for Subcutaneous Administration
Study Locations (13)
California
- Study Site - Los Angeles
- Study Site - Los Angeles
Indiana
- Study Site - Fort Wayne
- Study Site - Indianapolis
Colorado
- Study Site - Centennial
Florida
- Study Site - North Palm Beach
Georgia
- Study Site - Atlanta
Iowa
- Study Site - Iowa City
Missouri
- Study Site - St Louis
New Jersey
- Study Site - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2006-11 |
| Est. Completion | 2008-10 |
| Phase | Phase 3 |
What the finished NCT00419341 record still lists
NCT00419341 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 1,195-participant average among 5 other Primary Immune Deficiency trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Primary Immune Deficiency appearing as the primary indexed condition, and to 1 intervention - of which Human Normal Immunoglobulin for Subcutaneous Administration is the first listed.
NCT00419341 lists 13 locations in 11 states (California, Indiana, Colorado).
Frequently Asked Questions
What is clinical trial NCT00419341 about?
NCT00419341 is a clinical study titled "Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy". The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).
What is the current status of trial NCT00419341?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 49 participants. The study started on 2006-11. Estimated completion is 2008-10.
What conditions does trial NCT00419341 study?
This clinical trial studies the following conditions: Primary Immune Deficiency.
What interventions are being tested in trial NCT00419341?
The interventions under investigation include: Human Normal Immunoglobulin for Subcutaneous Administration (BIOLOGICAL).
Who is sponsoring clinical trial NCT00419341?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00419341 being conducted?
This trial has 13 study locations across California, Colorado, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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