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

This study has been completed.

Sponsored by: Talecris Biotherapeutics
Information provided by: Talecris Biotherapeutics
ClinicalTrials.gov Identifier: NCT00220727
  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 Intravenous [Human], 10% Caprylate/Chromatography Purified
Phase II

Genetics Home Reference related topics:   hemophilia    thrombotic thrombocytopenic purpura   

ChemIDplus related topics:   Globulin, Immune    Immunoglobulins    Caprylic acid   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Safety Study
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)

Further study details as provided by Talecris Biotherapeutics:

Primary Outcome Measures:
  • Hemolysis [ Time Frame: 1 Day after treatment ]

Secondary Outcome Measures:
  • All adverse events [ Time Frame: 7 Days after treatment ]
  • Infusion related adverse events [ Time Frame: 48 hours after treatment ]

Enrollment:   8
Study Start Date:   July 2003
Study Completion Date:   October 2003

Arms Assigned Interventions
Group 1: Experimental
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 Intravenous [Human], 10% Caprylate/Chromatography Purified
Group 2: Experimental
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 Intravenous [Human], 10% Caprylate/Chromatography Purified

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 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 10E9/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 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 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

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
Talecris Biotherapeutics

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

Study Synopsis of Results  This link exits the ClinicalTrials.gov site
 
FDA-Approved Product Labeling - Gamunex®  This link exits the ClinicalTrials.gov site
 
FDA Product Approval - Gamunex®  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   100422
First Received:   September 13, 2005
Last Updated:   March 31, 2008
ClinicalTrials.gov Identifier:   NCT00220727
Health Authority:   United States: Food and Drug Administration

Keywords provided by Talecris Biotherapeutics:
Idiopathic (Immune) Thrombocytopenia Purpura  
Immunoglobulin G  

Study placed in the following topic categories:
Purpura
Autoimmune Diseases
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hemostatic Disorders
Purpura, Thrombocytopenic
Signs and Symptoms
Thrombocytopathy
Thrombocytopenia
Hemorrhagic Disorders
Immunoglobulins, Intravenous
Immunoglobulin G
Purpura, Thrombocytopenic, Idiopathic
Hemolysis
Rho(D) Immune Globulin
Immunoglobulins

Additional relevant MeSH terms:
Skin Manifestations
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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