Rapid Infusion Of Immune Globulin Intravenous (IGIV) In Patients With ITP
Randomized, Controlled, Open Study Investigating IGIV-C, 10% Given at Different Infusion Rates on Intravascular Hemolysis in Patients With Idiopathic (Immune) Thrombocytopenic Purpura (ITP)
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2003
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedResults Posted
Study results publicly available
August 20, 2014
CompletedApril 27, 2016
March 1, 2016
3 months
September 13, 2005
September 24, 2009
March 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Free Hemoglobin
Free hemoglobin as a measure to assess hemolysis.
24 hours after treatment
Hematocrit
Hematocrit as a measure to assess hemolysis
24 hrs after treatment
Red Blood Cells
Red blood cells as a measure to assess hemolysis
24 hrs after treatment
Change From Baseline in Platelet Levels
24 hours Post infusion and Day 7
Secondary Outcomes (1)
Number of Subjects With Infusion Related Adverse Events
48 hours after treatment
Study Arms (2)
Group 1
EXPERIMENTALInfusion #1 (Week 0) IGIV-C (0.08 mL/kg/min); Infusion #2 (Week \<6) IGIV-C (0.14 mL/kg/min)
Group 2
EXPERIMENTALInfusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week \<6) IGIV-C (0.08 mL/kg/min)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York Presbyterian Hospital
New York, New York, 10021-4885, United States
Related 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. doi: 10.1002/ajh.20822.
PMID: 17109385BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Henry Li
- Organization
- Grifols Therapeutics
Study Officials
- PRINCIPAL INVESTIGATOR
James Bussel, MD
New York Presbyterian Hospital-Weill Medical College of Cornell University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 22, 2005
Study Start
July 1, 2003
Primary Completion
October 1, 2003
Study Completion
October 1, 2003
Last Updated
April 27, 2016
Results First Posted
August 20, 2014
Record last verified: 2016-03