At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 59 enrolled
Drug / intervention
RI-002biological
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.
An Open Label, Multicenter, Study to Evaluate the Pharmacokinetics, Efficacy and Safety of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)
In Brief
A Phase 3 clinical trial evaluating RI-002 for Primary Immune Deficiency Disorder. Completed, enrolled 59 participants across 9 sites.
Detailed Summary
This is a Phase III, multicenter, open-label study of RI-002 administered as an intravenous infusion of RI-002 (IGIV) every 21 or 28 days in approximately 60 subjects with Primary Immunodeficiency Diseases (PIDD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Immune Deficiency Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 2013
Enrollment StartFeb 2014
Primary CompletionDec 2014
Study CompletionJan 2015
TodayJul 2026
First PostedMar 20, 2013
Enrollment StartFeb 1, 2014
Primary CompletionDec 1, 2014
Study CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.3 years ago
Interventions
RI-002biological
Immune Globulin Intravenous (IGIV)