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

March 28, 2016 updated by: Grifols Therapeutics LLC

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

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 Overview

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)

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10021-4885
        • New York Presbyterian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Infusion #1 (Week 0) IGIV-C (0.08 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.14 mL/kg/min)
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.
Other Names:
  • Gamunex®
  • IGIVnex®
  • Gaminex
  • IGIV-C
  • BAY 41-1000
  • TAL-05-00004
  • IGIV-C, 10%
  • IVIG
  • 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
Experimental: Group 2
Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.08 mL/kg/min)
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.
Other Names:
  • Gamunex®
  • IGIVnex®
  • Gaminex
  • IGIV-C
  • BAY 41-1000
  • TAL-05-00004
  • IGIV-C, 10%
  • IVIG
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Free Hemoglobin
Time Frame: 24 hours after treatment
Free hemoglobin as a measure to assess hemolysis.
24 hours after treatment
Hematocrit
Time Frame: 24 hrs after treatment
Hematocrit as a measure to assess hemolysis
24 hrs after treatment
Red Blood Cells
Time Frame: 24 hrs after treatment
Red blood cells as a measure to assess hemolysis
24 hrs after treatment
Change From Baseline in Platelet Levels
Time Frame: 24 hours Post infusion and Day 7
24 hours Post infusion and Day 7

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Subjects With Infusion Related Adverse Events
Time Frame: 48 hours after treatment
48 hours after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

October 1, 2003

Study Completion (Actual)

October 1, 2003

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

April 27, 2016

Last Update Submitted That Met QC Criteria

March 28, 2016

Last Verified

March 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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