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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Grifols Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00220727
First received: September 13, 2005
Last updated: August 19, 2014
Last verified: August 2014
  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.


Condition Intervention Phase
Purpura, Thrombocytopenic, Idiopathic
Drug: Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Grifols Therapeutics Inc.:

Primary Outcome Measures:
  • Free Hemoglobin [ Time Frame: 24 hours after treatment ] [ Designated as safety issue: Yes ]
    Free hemoglobin as a measure to assess hemolysis.

  • Hematocrit [ Time Frame: 24 hrs after treatment ] [ Designated as safety issue: Yes ]
    Hematocrit as a measure to assess hemolysis

  • Red Blood Cells [ Time Frame: 24 hrs after treatment ] [ Designated as safety issue: Yes ]
    Red blood cells as a measure to assess hemolysis

  • Change From Baseline in Platelet Levels [ Time Frame: 24 hours Post infusion and Day 7 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of Subjects With Infusion Related Adverse Events [ Time Frame: 48 hours after treatment ] [ Designated as safety issue: Yes ]

Enrollment: 8
Study Start Date: July 2003
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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.
Other Names:
  • 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
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)
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.
Other Names:
  • 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

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)
  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220727

Locations
United States, New York
New York Presbyterian Hospital
New York, New York, United States, 10021-4885
Sponsors and Collaborators
Grifols Therapeutics Inc.
Investigators
Principal Investigator: James Bussel, MD New York Presbyterian Hospital-Weill Medical College of Cornell University
  More Information

Additional Information:
Publications:
Responsible Party: Grifols Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00220727     History of Changes
Other Study ID Numbers: 100422
Study First Received: September 13, 2005
Results First Received: September 24, 2009
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Grifols Therapeutics Inc.:
Idiopathic (Immune) Thrombocytopenic Purpura
Immunoglobulin G

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Autoimmune Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hematologic Diseases
Hemorrhage
Hemorrhagic Disorders
Immune System Diseases
Pathologic Processes
Signs and Symptoms
Skin Manifestations
Thrombocytopenia
Thrombotic Microangiopathies
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 23, 2014