Phase 2
N=8
Rapid Infusion Of Immune Globulin Intravenous (IGIV) In Patients With ITP
Purpura, Thrombocytopenic, Idiopathic
Bottom Line
View on ClinicalTrials.gov: NCT00220727 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Free Hemoglobin — 13.057; 12.371 g/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Grifols Therapeutics LLC
- Primary completion
- Oct 2003
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Free Hemoglobin |
13.057; 12.371 | — |
| PRIMARY Hematocrit |
36.80; 35.043 | — |
| PRIMARY Red Blood Cells |
4.1514; 4.0786 | — |
| PRIMARY Change From Baseline in Platelet Levels |
29.50; 6.86; 21.17; 42.29; 76; 118.7 | — |
| SECONDARY Number of Subjects With Infusion Related Adverse Events |
2; 3 | — |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT00220727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.