At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 40 enrolled
Drug / intervention
IgPro20biological
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.
A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency (IgPro20 EU Extension Study)
In Brief
A Phase 3 clinical trial evaluating IgPro20 for Primary Immunodeficiency (PID). Completed, enrolled 40 participants across 13 sites in 8 countries.
Detailed Summary
This study is a continuation of the study ZLB06\_001CR with the objective of assessing efficacy, tolerability, safety of IgPro, as well as long-term health-related quality of life in patients with PID.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Immunodeficiency (PID)
CountriesFrance, Germany, Poland, Romania, Spain, Sweden, Switzerland, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2008
First PostedSep 2008
Primary CompletionDec 2011
TodayJul 2026
First PostedSep 12, 2008
Enrollment StartAug 1, 2008
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 17.8 years ago
Interventions
IgPro20biological