CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 82 enrolled
Drug / intervention
Immune Globulin Intravenous +1 morebiological
Likely dose
Prometic's Immune Globulin Intravenous 10% 50 mLfrom 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/NCT02269163
NCT02269163Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Open-Label Study of the Safety, Tolerability, Efficacy, and PK of ProMetic BioTherapeutics IGIV (Human) 10% in Adults and Children With Primary Immunodeficiency Diseases

Prometic Biotherapeutics, Inc.·interventional·Posted Oct 20, 2014·Updated Nov 5, 2021

In Brief

A Phase 3 clinical trial evaluating Immune Globulin Intravenous and Prometic's Immune Globulin Intravenous 10% for Primary Immunodeficiency. Completed, enrolled 82 participants across 13 sites.

Detailed Summary

Phase 3 multicenter, open-label study of safety, tolerability, efficacy, and pharmacokinetics (PK) of ProMetic's Immune Globulin Intravenous (Human) 10%, the investigational medicinal product \[IMP\]), in Adults and Children with Primary Immunodeficiency Diseases (PIDD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Immunodeficiency
CountriesUnited States
CollaboratorsAtlantic Research Group

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 20, 2014
Enrollment StartJan 26, 2016
Primary CompletionJan 11, 2019
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 11.7 years ago

Interventions

Immune Globulin Intravenousbiological

Gammargard, Gammaplex,Gamunex, or Octogam IGIV Product

Prometic's Immune Globulin Intravenous 10%biological

Liquid formulation of Prometic Immune Globulin Intravenous 10% (human) in 50 mL vials containing 100 mg/mL of immunoglobulin G (IgG)