Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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)


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.


Study is Available At:


Original ID:

100422


NCT ID:

NCT00220727


Secondary ID:


Study Acronym:


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)


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

12 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Grifols Therapeutics Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

8


Enrollment Type:

Actual


Overall Contact Information

Official Name:James Bussel, MD
Principal Investigator
New York Presbyterian Hospital-Weill Medical College of Cornell University

Study Dates

Start Date:July 2003
Completion Date:October 2003
Completion Type:Actual
Primary Completion Date:October 2003
Primary Completion Type:Actual
Verification Date:August 2014
Last Changed Date:August 19, 2014
First Received Date:September 13, 2005
First Results Date:September 24, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure:Free Hemoglobin
Time Frame:24 hours after treatment
Safety Issues:True
Description:Free hemoglobin as a measure to assess hemolysis.
Outcome Type:Primary Outcome
Measure:Hematocrit
Time Frame:24 hrs after treatment
Safety Issues:True
Description:Hematocrit as a measure to assess hemolysis
Outcome Type:Primary Outcome
Measure:Red Blood Cells
Time Frame:24 hrs after treatment
Safety Issues:True
Description:Red blood cells as a measure to assess hemolysis
Outcome Type:Primary Outcome
Measure:Change From Baseline in Platelet Levels
Time Frame:24 hours Post infusion and Day 7
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Number of Subjects With Infusion Related Adverse Events
Time Frame:48 hours after treatment
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:Immune Globulin IV [Human], 10% Caprylate/Chromato
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.
Arm Name:Group 1
Other Name:Gamunex®

Study Arms

Study Arm Type:Experimental
Arm Name:Group 1
Description:Infusion #1 (Week 0) IGIV-C (0.08 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.14 mL/kg/min)
Study Arm Type:Experimental
Arm Name:Group 2
Description:Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.08 mL/kg/min)

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Grifols Therapeutics Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
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.
PMID:17109385

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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