CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 51 enrolled
Drug / intervention
Human Normal Immunoglobulin for Subcutaneous Administration (IGSC)biological
Likely dose
Not stated in 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/NCT00542997
NCT00542997Phase 3Completed
CompareCT.gov

A Multicentre Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency

CSL Behring·interventional·Posted Oct 12, 2007·Updated Sep 1, 2011

In Brief

A Phase 3 clinical trial evaluating Human Normal Immunoglobulin for Subcutaneous Administration (IGSC) for Common Variable Immunodeficiency and 2 related conditions. Completed, enrolled 51 participants across 19 sites in 9 countries.

Detailed Summary

The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCommon Variable Immunodeficiency, X-linked Agammaglobulinemia, Autosomal Recessive Agammaglobulinemia
CountriesFrance, Germany, Italy, Poland, Romania, Spain, Sweden, Switzerland, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 12, 2007
Enrollment StartSep 1, 2007
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 18.7 years ago

Interventions

Human Normal Immunoglobulin for Subcutaneous Administration (IGSC)biological

IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. The initial weekly dose was determined based on subjects' previous treatment. Dose adjustments could be performed during the wash-in/wash-out period at the discretion of the investigator.