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A Clinical Study of Intravenous Immunoglobulin

NCT00468273 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2014-08-11

No results posted yet for this study

Summary

The purpose of this study is to measure the pharmacokinetics, efficacy and safety of Immune Globulin Intravenous (Human) \[IGIV\], 5% Solution Omr-IgG-am™ in patients with primary immunodeficiency diseases.

Conditions

  • Immunologic Deficiency Syndromes

Interventions

DRUG

Immune Globulin Intravenous (Human) Omr-IgG-am IGIV

IGIV infusions of 300-900 mg/kg every 3 or 4 weeks

Sponsors & Collaborators

  • OMRIX Biopharmaceuticals

    collaborator INDUSTRY

  • FFF Enterprises

    lead INDUSTRY

Principal Investigators

  • Chaim Roifman, MD · The Hospital for Sick Children

  • Robert Roberts, MD · Mattel Children's Hospital of UCLA

  • Isaac R Melamed, MD · 1st Allergey and Clinical Research Center

  • James Moy, MD · Rush Universitity Medical Centre

  • Eyal Grunebaum, MD · The Hospital for Sick Children

  • Gordan L Sussman, MD · University of Toronto

  • Akhilesh Chouksey, MD · Rainbow Babies and Children's Hospital

  • Mark Stein, MD · Allergy Associates of the Palm Beaches

  • Richard L Wasserman, MD

  • Daniel Suez, MD · Allergy, Asthma and Immunology Clinic PA

  • Don McNeil, MD · Optimed Research LLC

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2009-05-31
Completion
2009-08-31

Countries

  • United States
  • Canada

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 NCT00468273 on ClinicalTrials.gov