A Safety Study of Intravenous Immunoglobulin in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)
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|ClinicalTrials.gov Identifier: NCT01390649|
Recruitment Status : Completed
First Posted : July 11, 2011
Results First Posted : October 19, 2015
Last Update Posted : April 8, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Immune Thrombocytopenic Purpura||Biological: IgPro10||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Prospective, Multicenter Study to Investigate the Specificity of in Vivo Antibody Binding to Red Blood Cells in Subjects With Chronic Immune Thrombocytopenic Purpura (ITP) Treated With IgPro10 (Privigen®) Who Have Shown Signs of Hemolysis|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
IgPro10 will be administrated by IV infusion either a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first treatment.
Other Name: Privigen
- Set of Antibodies Most Frequently Bound to Red Blood Cells (RBCs) in Subjects Experiencing Clinically Significant Intravascular Hemolysis [ Time Frame: Within 3 days of infusion ]The occurrence of clinically significant intravascular hemolysis was determined by an independent Adjudication Committee. No subject experienced clinically significant intravascular hemolysis; therefore, the primary safety endpoint could not be analyzed.
- Responder Rate [ Time Frame: Within 6 days after the first infusion ]The responder rate is the percentage of subjects who have a platelet response (defined as a platelet count increase at least once to ≥ 50 x 10^9/L after the first IgPro10 administration).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01390649
|UMHAT "Dr. Georgi Stranski" Clinic of Haematology|
|UMHAT "Sv. Georgi" Clinic of Haematology|
|Emergency Clinical County Hospital Baia Mare|
|Baia Mare, Romania|
|Emergency Clinical County Hospital Brasov|
|Clinical Institute "Fundeni"|
|Clinical City Hospital "Filantropia"|
|City Hospital Oradea|
|Emergency Clinical County Hospital Tg. Mures|
|Tg. Mures, Romania|
|Emergency Clinical City Hospital Timisoara|
|Clinical Center of Serbia|
|Clinical Hospital Bezanijska Kosa|
|Clinical Hospital Zemun|
|Clinical Center Nis|
|Principal Investigator:||Wieslaw Jedrzejczak||Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie|