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

Information source: Talecris Biotherapeutics
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Purpura, Thrombocytopenic, Idiopathic

Intervention: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Talecris Biotherapeutics

Official(s) and/or principal investigator(s):
James Bussel, MD, Principal Investigator, Affiliation: New York Presbyterian Hospital-Weill Medical College of Cornell University

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.

Clinical Details

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 design: Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Safety Study

Primary outcome: Hemolysis

Secondary outcome:

All adverse events

Infusion related adverse events

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

Minimum age: 12 Years. Maximum age: 75 Years. Gender(s): Both.

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.

Locations and Contacts

New York Presbyterian Hospital, New York, New York 10021-4885, United States
Additional Information

Study Synopsis of Results

FDA-Approved Product Labeling - Gamunex®

FDA Product Approval - Gamunex®

Related publications:

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.

Starting date: July 2003
Ending date: October 2003
Last updated: March 31, 2008

Page last updated: June 20, 2008

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