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

Phase 2

Completed

Conditions: Purpura, Thrombocytopenic, Idiopathic

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

Registration Number: NCT00220727

Lead Sponsor: Grifols Therapeutics LLC

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)

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 8

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified	Infusion #1 (Week 0) IGIV-C (0.08 mL/kg/min); Infusion #2 (Week \<6) IGIV-C (0.14 mL/kg/min)
Group 2	Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified	Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week \<6) IGIV-C (0.08 mL/kg/min)

Primary Outcome Measures

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