CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 25 enrolled
Drug / intervention
Immune Globulin Subcutaneous (Human) (SCIG)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/NCT01199705
NCT01199705Phase 3Completed
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A Multicenter Study of Efficacy, Safety, Tolerability, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency

CSL Behring·interventional·Posted Sep 13, 2010·Updated Dec 12, 2014

In Brief

A Phase 3 clinical trial evaluating Immune Globulin Subcutaneous (Human) (SCIG) for Primary Immune Deficiency. Completed, enrolled 25 participants across 10 sites.

Detailed Summary

The objective of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics of a subcutaneous immune globulin (SCIG; IgPro20) in subjects with primary immunodeficiency (PID). In addition, the study will assess the health-related quality of life and pharmacoeconomic aspects related to treatment with IgPro20.

Study Details

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

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 13, 2010
Enrollment StartSep 1, 2010
Primary CompletionAug 1, 2011
Study CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 15.8 years ago

Interventions

Immune Globulin Subcutaneous (Human) (SCIG)biological

IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human SCIG. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment.