Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00220727
Status:
COMPLETED
Last Update Posted:
2016-04-27
First Post:
2005-09-13
Brief Title:
Rapid Infusion Of Immune Globulin Intravenous IGIV In Patients With ITP
Sponsor:
Grifols Therapeutics LLC
Organization:
Grifols Therapeutics LLC
Study Overview
Official Title:
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
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to determine if the safety and tolerability of Immune Globulin Intravenous Human 10 CaprylateChromatograph 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 CaprylateChromatography Purified IGIV-C at a dose of 10 gkg will be given on 2 occasions as a single daily infusion for platelet counts 30000 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 008 mLkgmin and their second infusion at a rate of 014 mLkgmin Conversely patients randomized to Group 2 will receive their first IGIV-C infusion at a rate of 014 mLkgmin and their second infusion at a rate of 008 mLkgmin according to the following schema
Group 1
Infusion 1 Week 0 IGIV-C 008 mLkgmin
Infusion 2 Week 6 IGIV-C 014 mLkgmin
Group 2
Infusion 1 Week 0 IGIV-C 014 mLkgmin
Infusion 2 Week 6 IGIV-C 008 mLkgmin
Immune Globulin Intravenous Human 10 CaprylateChromatography Purified IGIV-C at a dose of 10 gkg will be given on 2 occasions as a single daily infusion for platelet counts 30000 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 008 mLkgmin and their second infusion at a rate of 014 mLkgmin Conversely patients randomized to Group 2 will receive their first IGIV-C infusion at a rate of 014 mLkgmin and their second infusion at a rate of 008 mLkgmin according to the following schema
Group 1
Infusion 1 Week 0 IGIV-C 008 mLkgmin
Infusion 2 Week 6 IGIV-C 014 mLkgmin
Group 2
Infusion 1 Week 0 IGIV-C 014 mLkgmin
Infusion 2 Week 6 IGIV-C 008 mLkgmin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None