NCT01814800

Pharmacokinetics, Efficacy, and Safety Study of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)

An Open Label, Multicenter, Study to Evaluate the Pharmacokinetics, Efficacy and Safety of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: ADMA Biologics, Inc. · Industry
• Sex: All
• Age: 2 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Primary immunodeficiency diseases (PIDDs) are genetically determined disorders of the immune system resulting in greatly enhanced susceptibility to infectious disease, autoimmunity and malignancy. As most subjects with PIDDs present with infections, the differential diagnosis and initial investigations for an underlying immune defect are typically guided by the clinical presentation. In subjects with PIDDs, individual infections are not necessarily more severe than those that occur in a normal host. Rather, the clinical features suggestive of an immune defect may be the recurring and/or chronic nature of infections with common pathogens that may result in end organ damage, such as bronchiectasis. Several immune globulin products have already been approved by the FDA.

Conditions

• Primary Immune Deficiency Disorder

Interventions

Type	Name	Description
BIOLOGICAL	RI-002	Immune Globulin Intravenous (IGIV)

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-12-01
• Completion: 2015-01-01
• First posted: 2013-03-20
• Last updated: 2016-10-05
• Results posted: 2016-10-05

Locations

9 sites across 1 country: United States