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Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients

NCT00220766 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2009-09-25

No results posted yet for this study

Summary

The objective of this study is to determine if the safety and tolerability of Immune Globulin Intravenous (Human), 10% caprylate/chromatography (IGIV-C)purified is similar when infused at two different infusion rates. The primary objective is to compare the incidence and severity of all infusion related adverse events when IGIV-C, 10% is administered at a rate of 0.14 mL/kg/min compared to a rate of 0.08 mL/kg/min after a single daily infusion.

Conditions

  • Immunologic Deficiency Syndrome
  • Agammaglobulinemia
  • Severe Combined Immunodeficiency
  • Wiskott-Aldrich Syndrome
  • Common Variable Immunodeficiency

Interventions

DRUG

Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified

DRUG

Dextrose, 5% in Water

Sponsors & Collaborators

  • Grifols Therapeutics LLC

    lead INDUSTRY

Principal Investigators

  • Erwin Gelfand, MD · National Jewish Medical and Research Center, Denver, CO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2002-08-31
Primary Completion
2002-08-31
Completion
2004-03-31

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 NCT00220766 on ClinicalTrials.gov