CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 23 enrolled
Drug / intervention
Immune globulin subcutaneous (Human)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/NCT01458171
NCT01458171Phase 3Completed
CompareCT.gov

A Multicenter Follow-up Study of Long-term Safety, Tolerability, and Efficacy of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency

CSL Behring·interventional·Posted Oct 24, 2011·Updated Apr 9, 2013

In Brief

A Phase 3 clinical trial evaluating Immune globulin subcutaneous (Human) for Primary Immune Deficiency Disorder. Completed, enrolled 23 participants across 9 sites.

Detailed Summary

The objective of this study is to assess the long-term safety, tolerability, and efficacy of IgPro20 in subjects with primary immunodeficiency (PID) as a follow-up to the pivotal study ZLB06\_002CR (NCT01199705).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Immune Deficiency Disorder
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 24, 2011
Enrollment StartApr 1, 2011
Primary CompletionFeb 1, 2012
Study CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 14.7 years ago

Interventions

Immune globulin subcutaneous (Human)biological

IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06\_002CR (NCT01199705).