CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 55 enrolled
Drug / intervention
Immunoglobulins Intravenous (Human)drug
Likely dose
Immunoglobulins Intravenous (Human) 0.8 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00322556
NCT00322556Phase 3Completed
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A Multicenter Extension Study on the Safety and Efficacy of IgPro10 in Patients With Primary Immunodeficiency (PID)

CSL Behring·interventional·Posted May 8, 2006·Updated Oct 26, 2012

In Brief

A Phase 3 clinical trial evaluating Immunoglobulins Intravenous (Human) for Agammaglobulinemia and 2 related conditions. Completed, enrolled 55 participants across 10 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAgammaglobulinemia, IgG Deficiency, Common Variable Immunodeficiency
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 8, 2006
Enrollment StartNov 1, 2005
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 20.2 years ago

Interventions

Immunoglobulins Intravenous (Human)drug

Liquid formulation; treatment schedule every 3 or 4 weeks using an individualized regimen with a dose of 0.2 - 0.8 g IgG per kg bw