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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

Page last updated: August 23, 2015

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