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

NCT01814800 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2016-10-05

Study results available
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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).

Conditions

  • Primary Immune Deficiency Disorder

Interventions

BIOLOGICAL

RI-002

Immune Globulin Intravenous (IGIV)

Sponsors & Collaborators

  • ADMA Biologics, Inc.

    lead INDUSTRY

Principal Investigators

  • James Mond, M.D., Ph.D. · ADMA Biologics, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-12-31
Completion
2015-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01814800 on ClinicalTrials.gov