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Safety and Efficacy Study of Flebogamma 5% DIF IGIV in Pediatric Subjects

NCT00634569 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-02-02

Study results available
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Summary

This is a multi-center, open-label study to assess the efficacy and safety of Flebogamma 5% DIF in the pediatric population.

Conditions

  • Primary Immune Deficiency Disease

Interventions

BIOLOGICAL

Flebogamma 5% DIF

Intravenous Immune Globulin (Human)

Sponsors & Collaborators

  • Instituto Grifols, S.A.

    lead INDUSTRY

Principal Investigators

  • Mark Ballow, MD · Children's Hospital of Buffalo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2011-03-31
Completion
2011-05-31

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 NCT00634569 on ClinicalTrials.gov