Phase 4
N=57
A Safety Study of Intravenous Immunoglobulin in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)
Immune Thrombocytopenic Purpura
Bottom Line
View on ClinicalTrials.gov: NCT01390649 ↗Enrolled (actual)
57
Serious AEs
1.8%
Results posted
Oct 2015
Primary outcome: Primary: Set of Antibodies Most Frequently Bound to Red Blood Cells (RBCs) in Subjects Experiencing Clinically Significant Intravascular Hemolysis
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- IgPro10 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CSL Behring
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Set of Antibodies Most Frequently Bound to Red Blood Cells (RBCs) in Subjects Experiencing Clinically Significant Intravascular Hemolysis |
— | — |
| SECONDARY Responder Rate |
74 | — |
Summary
It is known that intravenous immunoglobulins can induce hemolysis, but the mechanism is not known in detail. The primary objective of this study was to investigate the specificity of antigens on red blood cells in patients with chronic immune thrombocytopenic purpura (ITP) who have shown signs of clinically relevant hemolysis following treatment with the intravenous immunoglobin Privigen®. The study was to explore potential mechanisms of hemolysis by analysis of the specificity of the antibodies possibly involved. To distinguish between clinically non-relevant hemolysis and a relevant intravascular hemolysis, an independent adjudication by a committee was performed for each patient with signs of hemolysis determined in the laboratory or in the clinic.
This study was requested as a post-marketing commitment study by the United States Food and Drug Administration (FDA). By September 2014, no case of clinically significant intravascular hemolysis was found, and the FDA agreed to halt the study and analyze all hemolysis-relevant endpoints using FDA criteria for hemolysis in addition to analyses planned in the protocol. The study was not restarted.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of chronic ITP
- Age of 18 to 65 years
- Platelet count of ≤ 30 x 10^9/L at screening
Exclusion Criteria
- Planned splenectomy throughout the study period
- Treatment with immunoglobulin G for intravenous administration (IVIG) or anti-D immunoglobulin within 3 weeks prior to screening
- Use of drugs that have any pharmacological effect on the blood clotting system within 3 weeks prior to screening
- Known allergy or other severe reactions to blood products including intolerability to previous IVIG
- Known hyperprolinemia
- Red blood cell transfusion or erythropoietin treatment within the last 14 days
Data sourced from ClinicalTrials.gov (NCT01390649). 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.