A Safety Study of Intravenous Immunoglobulin in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)

Phase 4

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
IgPro10	IgPro10	-

Primary Outcome Measures

Name	Time	Method
Set of Antibodies Most Frequently Bound to Red Blood Cells (RBCs) in Subjects Experiencing Clinically Significant Intravascular Hemolysis	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.

Secondary Outcome Measures

Name	Time	Method
Responder Rate	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).

Locations (17): UMHAT "Dr. Georgi Stranski" Clinic of Haematology
🇧🇬
Pleven, Bulgaria
Emergency Clinical County Hospital Baia Mare
🇷🇴
Baia Mare, Romania
Emergency Clinical County Hospital Brasov
🇷🇴
Brasov, Romania
Clinical Institute "Fundeni"
🇷🇴
Bucharest, Romania
City Hospital Oradea
🇷🇴
Oradea, Romania
Oncomed SRL
🇷🇴
Timisoara, Romania
Salvo-San-Ciobanca SRL
🇷🇴
Zalau, Romania
Clinical Center of Serbia
🇷🇸
Belgrade, Serbia
Clinical Hospital Bezanijska Kosa
🇷🇸
Belgrade, Serbia
Clinical Hospital Zemun
🇷🇸
Belgrade, Serbia
Clinical Center Nis
🇷🇸
Nis, Serbia
UMHAT "Sv. Georgi" Clinic of Haematology
🇧🇬
Plovdiv, Bulgaria
Tokuda Hospital
🇧🇬
Sofia, Bulgaria
Universitary Hospital
🇷🇴
Bucharest, Romania
Clinical City Hospital "Filantropia"
🇷🇴
Craiova, Romania
Emergency Clinical County Hospital Tg. Mures
🇷🇴
Tg. Mures, Romania
Emergency Clinical City Hospital Timisoara
🇷🇴
Timisoara, Romania