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Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders

NCT00157079 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2021-08-24

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and efficacy of Immune Globulin Intravenous (Human), 10% (IGIV 10%) in subjects with primary immunodeficiency disorders.

Conditions

  • Primary Immunodeficiency Diseases (PID)
  • Immune Thrombocytopenic Purpura (ITP)
  • Kawasaki Syndrome

Interventions

BIOLOGICAL

Immune Globulin Intravenous (Human), 10%

Sponsors & Collaborators

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
CROSSOVER

Eligibility

Min Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-25
Primary Completion
2003-12-16
Completion
2003-12-16
FDA Drug
Yes

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 NCT00157079 on ClinicalTrials.gov