A Safety Study of Intravenous Immunoglobulin in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)
Information source: CSL Behring
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Immune Thrombocytopenic Purpura
Intervention: IgPro10 (Biological)
Phase: Phase 4
Status: Completed
Sponsored by: CSL Behring Official(s) and/or principal investigator(s):
Wieslaw Jedrzejczak, Principal Investigator, Affiliation: Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
Summary
It is known that intravenous immunoglobulins can induce red blood cell destruction, but the
mechanism is not known in detail. The primary objective of this study is 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 red blood cell destruction
following treatment with the immunoglobin Privigen®. The study will explore potential
mechanisms of red blood cell destruction by analysis of the specificity of the antibodies
possibly involved. To distinguish between clinically non relevant red blood cell destruction
and a relevant destruction, an independent adjudication by a committee will be performed for
each patient with signs of destruction determined in the laboratory or in the clinic.
Clinical Details
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 design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Set of antibodies most frequently bound to red blood cells (RBCs) in subjects experiencing clinically significant intravascular hemolysis
Secondary outcome: Responder rate
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
- RBC transfusion or erythropoietin treatment within the last 14 days
Locations and Contacts
UMHAT "Dr. Georgi Stranski" Clinic of Haematology, Pleven, Bulgaria
UMHAT "Sv. Georgi" Clinic of Haematology, Plovdiv, Bulgaria
National Haematological Hospital, Sofia, Bulgaria
Tokuda Hospital, Sofia, Bulgaria
MTZ Clinical Research Sp.z.o.o., Warszawa, Poland
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, Romania
Clinical Center of Serbia, Belgrade, Serbia
Clinical Hospital Bezanijska Kosa, Belgrade, Serbia
Clinical Hospital Zemun, Belgrade, Serbia
Clinical Center Kragujevac, Kragujevac, Serbia
Clinical Center Nis, Nis, Serbia
Clinical Center Novi Sad, Novi Sad 21000, Serbia
Additional Information
Starting date: November 2011
Last updated: October 17, 2014
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