Immune Thrombocytopenic Purpura Clinical Trial
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
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.
Status | Completed |
Enrollment | 57 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Bulgaria | UMHAT "Dr. Georgi Stranski" Clinic of Haematology | Pleven | |
Bulgaria | UMHAT "Sv. Georgi" Clinic of Haematology | Plovdiv | |
Bulgaria | Tokuda Hospital | Sofia | |
Romania | Emergency Clinical County Hospital Baia Mare | Baia Mare | |
Romania | Emergency Clinical County Hospital Brasov | Brasov | |
Romania | Clinical Institute "Fundeni" | Bucharest | |
Romania | Universitary Hospital | Bucharest | |
Romania | Clinical City Hospital "Filantropia" | Craiova | |
Romania | City Hospital Oradea | Oradea | |
Romania | Emergency Clinical County Hospital Tg. Mures | Tg. Mures | |
Romania | Emergency Clinical City Hospital Timisoara | Timisoara | |
Romania | Oncomed SRL | Timisoara | |
Romania | Salvo-San-Ciobanca SRL | Zalau | |
Serbia | Clinical Center of Serbia | Belgrade | |
Serbia | Clinical Hospital Bezanijska Kosa | Belgrade | |
Serbia | Clinical Hospital Zemun | Belgrade | |
Serbia | Clinical Center Nis | Nis |
Lead Sponsor | Collaborator |
---|---|
CSL Behring |
Bulgaria, Romania, Serbia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Set of Antibodies Most Frequently Bound to Red Blood Cells (RBCs) in Subjects Experiencing Clinically Significant Intravascular Hemolysis | 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. | Within 3 days of infusion | Yes |
Secondary | Responder Rate | 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). | Within 6 days after the first infusion | No |
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