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Rapid Infusion Of Immune Globulin Intravenous (IGIV) In Patients With ITP

NCT00220727 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2016-04-27

Study results available
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Summary

The objective of this study is to determine if the safety and tolerability of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatograph Purified (IGIV-C) is similar when infused at two different infusion rates.

Conditions

  • Purpura, Thrombocytopenic, Idiopathic

Interventions

DRUG

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

IGIV-C 10% at a dose of 1.0g/kg was to be given on 2 occasions as a single daily infusion: Group 1 were to receive their first IGIV-C, 10-% infusion at a rate of 0.08 mL/kg/min and a second infusion at 0.14 mL/kg/min. and Group 2 were to receive their first IGIV-C, 10-% infusion at a rate of 0.14 mL/kg/min and a second infusion at a rate of 0.08 mL/kg/min.

Sponsors & Collaborators

  • Grifols Therapeutics LLC

    lead INDUSTRY

Principal Investigators

  • James Bussel, MD · New York Presbyterian Hospital-Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2003-10-31
Completion
2003-10-31

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 NCT00220727 on ClinicalTrials.gov