At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 81 enrolled
Drug / intervention
IgG Next Generation (BT595)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.
An Open-label, Prospective, Multicenter Study Investigating Clinical Efficacy, Safety, and Pharmacokinetic Properties of the Human Normal Immunoglobulin for Intravenous Administration BT595 as Replacement Therapy in Patients With Primary Immunodeficiency Disease (PID)
In Brief
A Phase 3 clinical trial evaluating IgG Next Generation (BT595) for Primary Immunodeficiency Disease. Completed, enrolled 81 participants across 19 sites in 5 countries.
Detailed Summary
This Phase III clinical study is to test efficacy, safety and pharmacokinetics of BT595 in treating patients with Primary Immunodeficiency (PID)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Immunodeficiency Disease
CountriesGermany, Hungary, Russia, Spain, United States
CollaboratorsSyneos Health
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 2016
Enrollment StartOct 2016
Primary CompletionApr 2020
TodayJul 2026
First PostedJun 23, 2016
Enrollment StartOct 4, 2016
Primary CompletionApr 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 10.0 years ago
Interventions
IgG Next Generation (BT595)biological