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

Primary Purpose

Purpura, Thrombocytopenic, Idiopathic

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified
Sponsored by
Grifols Therapeutics LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Purpura, Thrombocytopenic, Idiopathic focused on measuring Idiopathic (Immune) Thrombocytopenic Purpura, Immunoglobulin G

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Written informed consent from patient or legal guardian (according to institutional review board requirements)obtained prior to initiation of any study related procedures Male and female subjects age between 12 and 75 years Confirmed diagnosis of ITP logged in medical records available prior to entry into the trial. Patients must have a platelet count < 30 x Giga/L (this level can be higher if clinically indicated). Previously splenectomized patients may be included. Any previously conducted bone marrow aspirations if conducted following diagnosis of ITP must be consistent with the ITP diagnosis (increased or normal levels of megakaryocytes in otherwise normal bone marrow). Exclusion Criteria: History of allergic or other clinically significant reaction to human gamma globulin or other plasma proteins and/or blood products. Female patient who is pregnant or lactating or is not on an adequate program of contraception if of child-bearing potential. Documented history of selective immunoglobulin A (IgA) deficiency (serum <5.0 mg/dL) and known antibodies to IgA. Currently on intermittent prednisone therapy. Prednisone therapy is allowed only if the patient has been on stable daily doses of prednisone for the preceding month and maintains the same treatment regimen throughout the study. Renal or liver impairment defined by creatinine > 2.5 mg/dL, or direct bilirubin >1.5 X the upper limit of normal or liver transaminases (AST or ALT) > 3 times the upper limit of normal. Received anti-D or IGIV infusions within the past 14 days Pre-treatment with the exception of acetominophen, routinely required to control/ameliorate IGIV infusion-related adverse events (AEs), or any patient who has been, unresponsive to IGIV therapy for their ITP History or clinical evidence of medical conditions felt to be the underlying cause of their thrombocytopenia. Such conditions commonly include systemic lupus erythematosus, history of chronic lymphocytic leukemia, dysplasia, agammaglobulinemia, treatment with heparin, quinidine, quinine, trimethoprim-sulfamethoxazole, or ticlopidine or any other drug thought to be the cause of patient's thrombocytopenia, congenital or hereditary thrombocytopenia, or pseudothrombocytopenia (clumping on peripheral blood smear) Conditions that could alter protein catabolism and/or immunoglobulin G (IgG) utilization (e.g. protein-losing enteropathies, nephrotic syndrome) Congestive heart failure (New York Heart Association Stage III or IV) Diabetes mellitus Paraproteinemia Concomitant nephrotoxic drugs Hemoglobin level more than 2g/L below the lower limit of normal.

Sites / Locations

  • New York Presbyterian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

Infusion #1 (Week 0) IGIV-C (0.08 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.14 mL/kg/min)

Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.08 mL/kg/min)

Outcomes

Primary Outcome Measures

Free Hemoglobin
Free hemoglobin as a measure to assess hemolysis.
Hematocrit
Hematocrit as a measure to assess hemolysis
Red Blood Cells
Red blood cells as a measure to assess hemolysis
Change From Baseline in Platelet Levels

Secondary Outcome Measures

Number of Subjects With Infusion Related Adverse Events

Full Information

First Posted
September 13, 2005
Last Updated
March 28, 2016
Sponsor
Grifols Therapeutics LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00220727
Brief Title
Rapid Infusion Of Immune Globulin Intravenous (IGIV) In Patients With ITP
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
October 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grifols Therapeutics LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Purpura, Thrombocytopenic, Idiopathic
Keywords
Idiopathic (Immune) Thrombocytopenic Purpura, Immunoglobulin G

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Infusion #1 (Week 0) IGIV-C (0.08 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.14 mL/kg/min)
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.08 mL/kg/min)
Intervention Type
Drug
Intervention Name(s)
Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified
Other Intervention Name(s)
Gamunex®, IGIVnex®, Gaminex, IGIV-C, IGIV-C, 10%, IVIG, BAY 41-1000, TAL-05-00004, Immune Globulin (Human), 10% (IGIV), Immune Globulin Intravenous, 10% by Chromatography Process, NDC 13533-645-12, NDC 13533-645-15, NDC 13533-645-20, NDC 13533-645-24, NDC 13533-645-71
Intervention Description
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.
Primary Outcome Measure Information:
Title
Free Hemoglobin
Description
Free hemoglobin as a measure to assess hemolysis.
Time Frame
24 hours after treatment
Title
Hematocrit
Description
Hematocrit as a measure to assess hemolysis
Time Frame
24 hrs after treatment
Title
Red Blood Cells
Description
Red blood cells as a measure to assess hemolysis
Time Frame
24 hrs after treatment
Title
Change From Baseline in Platelet Levels
Time Frame
24 hours Post infusion and Day 7
Secondary Outcome Measure Information:
Title
Number of Subjects With Infusion Related Adverse Events
Time Frame
48 hours after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent from patient or legal guardian (according to institutional review board requirements)obtained prior to initiation of any study related procedures Male and female subjects age between 12 and 75 years Confirmed diagnosis of ITP logged in medical records available prior to entry into the trial. Patients must have a platelet count < 30 x Giga/L (this level can be higher if clinically indicated). Previously splenectomized patients may be included. Any previously conducted bone marrow aspirations if conducted following diagnosis of ITP must be consistent with the ITP diagnosis (increased or normal levels of megakaryocytes in otherwise normal bone marrow). Exclusion Criteria: History of allergic or other clinically significant reaction to human gamma globulin or other plasma proteins and/or blood products. Female patient who is pregnant or lactating or is not on an adequate program of contraception if of child-bearing potential. Documented history of selective immunoglobulin A (IgA) deficiency (serum <5.0 mg/dL) and known antibodies to IgA. Currently on intermittent prednisone therapy. Prednisone therapy is allowed only if the patient has been on stable daily doses of prednisone for the preceding month and maintains the same treatment regimen throughout the study. Renal or liver impairment defined by creatinine > 2.5 mg/dL, or direct bilirubin >1.5 X the upper limit of normal or liver transaminases (AST or ALT) > 3 times the upper limit of normal. Received anti-D or IGIV infusions within the past 14 days Pre-treatment with the exception of acetominophen, routinely required to control/ameliorate IGIV infusion-related adverse events (AEs), or any patient who has been, unresponsive to IGIV therapy for their ITP History or clinical evidence of medical conditions felt to be the underlying cause of their thrombocytopenia. Such conditions commonly include systemic lupus erythematosus, history of chronic lymphocytic leukemia, dysplasia, agammaglobulinemia, treatment with heparin, quinidine, quinine, trimethoprim-sulfamethoxazole, or ticlopidine or any other drug thought to be the cause of patient's thrombocytopenia, congenital or hereditary thrombocytopenia, or pseudothrombocytopenia (clumping on peripheral blood smear) Conditions that could alter protein catabolism and/or immunoglobulin G (IgG) utilization (e.g. protein-losing enteropathies, nephrotic syndrome) Congestive heart failure (New York Heart Association Stage III or IV) Diabetes mellitus Paraproteinemia Concomitant nephrotoxic drugs Hemoglobin level more than 2g/L below the lower limit of normal.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Bussel, MD
Organizational Affiliation
New York Presbyterian Hospital-Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021-4885
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17109385
Citation
Bussel JB, Hanna K; IGIV-C in ITP Study Group. Safety and tolerability of a novel chromatography-based intravenous immunoglobulin when administered at a high infusion rate in patients with immune thrombocytopenic purpura. Am J Hematol. 2007 Mar;82(3):192-8. doi: 10.1002/ajh.20822.
Results Reference
background
Links:
URL
http://www.talecris-pi.info/inserts/gamunex.pdf
Description
FDA-Approved Product Labeling - Gamunex®
URL
http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm089390.htm
Description
FDA Product Approval - Gamunex®

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

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