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

NCT ID: NCT00220727

Last Updated: 2016-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2003-10-31

Brief 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.

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)

Conditions

Purpura, Thrombocytopenic, Idiopathic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 Type: EXPERIMENTAL

Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified

Intervention Type: DRUG

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.

Group 2

Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week \<6) IGIV-C (0.08 mL/kg/min)

Group Type: EXPERIMENTAL

Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention 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

Eligibility 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grifols Therapeutics LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Bussel, MD

Role: PRINCIPAL_INVESTIGATOR

New York Presbyterian Hospital-Weill Medical College of Cornell University

Locations

New York Presbyterian Hospital

New York, New York, United States

Countries

United States

References

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. doi: 10.1002/ajh.20822.

Reference Type: BACKGROUND

PMID: 17109385 (View on PubMed)

Related Links

http://www.talecris-pi.info/inserts/gamunex.pdf

FDA-Approved Product Labeling - Gamunex®

http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm089390.htm

FDA Product Approval - Gamunex®

Other Identifiers

100422

Identifier Type: -

Identifier Source: org_study_id