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

Purpura, Thrombocytopenic, Idiopathic Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00220727
• Other study ID #: 100422
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: August 19, 2014
• Start date: July 2003
• Est. completion date: October 2003

Study information

• Verified date: August 2014
• Source: Grifols Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 2003
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

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.

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Grifols Therapeutics Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Free Hemoglobin	Free hemoglobin as a measure to assess hemolysis.	24 hours after treatment	Yes
Primary	Hematocrit	Hematocrit as a measure to assess hemolysis	24 hrs after treatment	Yes
Primary	Red Blood Cells	Red blood cells as a measure to assess hemolysis	24 hrs after treatment	Yes
Primary	Change From Baseline in Platelet Levels		24 hours Post infusion and Day 7	Yes
Secondary	Number of Subjects With Infusion Related Adverse Events		48 hours after treatment	Yes

External Links

•   FDA Product Approval - Gamunex®
•   FDA-Approved Product Labeling - Gamunex®