NCT00220727

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

Randomized, Controlled, Open Study Investigating IGIV-C, 10% Given at Different Infusion Rates on Intravascular Hemolysis in Patients With Idiopathic (Immune) Thrombocytopenic Purpura (ITP)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Grifols Therapeutics LLC · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, randomized, single-center, open, cross-over trial in patients with a confirmed diagnosis of Idiopathic Thrombocytopenia Purpura (ITP). ITP is defined as isolated thrombocytopenia in a patient with no other clinically apparent associated conditions or factors that are known to cause thrombocytopenia as defined by the ITP Practice Guidelines Committee of the American Society of Hematology. Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) at a dose of 1.0 g/kg will be given on 2 occasions as a single daily infusion for platelet counts \< 30,000 microliters (uL) or if clinically indicated, at maximum intervals of six weeks. Eligible patients will be randomized into one of two cross-over groups. Patients randomized to Group 1 will receive their first IGIV-C infusion at a rate of 0.08 mL/kg/min and their second infusion at a rate of 0.14 mL/kg/min. Conversely patients randomized to Group 2 will receive their first IGIV-C infusion at a rate of 0.14 mL/kg/min and their second infusion at a rate of 0.08 mL/kg/min according to the following schema: Group 1: * Infusion #1 (Week 0) IGIV-C (0.08 mL/kg/min) * Infusion #2 (Week \<6) IGIV-C (0.14 mL/kg/min) Group 2: * Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min) * Infusion #2 (Week \<6) IGIV-C (0.08 mL/kg/min)

Conditions

• Purpura, Thrombocytopenic, Idiopathic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2003-07-01
• Primary completion: 2003-10-01
• Completion: 2003-10-01
• First posted: 2005-09-22
• Last updated: 2016-04-27
• Results posted: 2014-08-20

Locations

1 site across 1 country: United States