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

Information source: CSL Behring
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Immune Thrombocytopenic Purpura

Intervention: IgPro10 (Biological)

Phase: Phase 4

Status: Recruiting

Sponsored by: CSL Behring

Official(s) and/or principal investigator(s):
Wieslaw Jedrzejczak, Principal Investigator, Affiliation: Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie

Overall contact:
Clinical Trial Registration Coordinator, Email: clinicaltrials@cslbehring.com

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

Clinical Trial Registration Coordinator, Email: clinicaltrials@cslbehring.com

UMHAT "Dr. Georgi Stranski" Clinic of Haematology, Pleven, Bulgaria; Recruiting
use central contact
Nikolai Tsvetkov, Assoc. Prof., Principal Investigator

UMHAT "Sv. Georgi" Clinic of Haematology, Plovdiv, Bulgaria; Recruiting
use central contact
Veselina Goranova-Marinova, Dr., Principal Investigator

National Haematological Hospital, Sofia, Bulgaria; Recruiting
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Georgi Mihaylov, Assoc. Prof., Principal Investigator

Tokuda Hospital, Sofia, Bulgaria; Recruiting
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Atanas Radinov, Principal Investigator

Haematology Hospital "Yoan Pavel", Sofia, Bulgaria; Withdrawn

MTZ Clinical Research Sp.z.o.o., Warszawa, Poland; Recruiting
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Wieslaw Jedrzejczak, Prof., Principal Investigator

Emergency Clinical County Hospital Baia Mare, Baia Mare, Romania; Recruiting
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Cristina Truica, Dr., Principal Investigator

Emergency Clinical County Hospital Brasov, Brasov, Romania; Recruiting
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Emanuil Gheorgita, Dr., Principal Investigator

Universitary Hospital, Bucharest, Romania; Recruiting
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Horia Bumbea, Dr., Principal Investigator

Clinical Institute "Fundeni", Bucharest, Romania; Recruiting
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Mariana Vasilica, Dr., Principal Investigator

Clinical Institute "Fundeni", Bucharest, Romania; Recruiting
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Emilia Mizil Niculescu, Dr., Principal Investigator

Clinical City Hospital "Filantropia", Craiova, Romania; Recruiting
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Luminita Ocroteala, Dr., Principal Investigator

Emergency Clinical County Hospital "Sf. Spiridon", Iasi, Romania; Withdrawn

City Hospital Oradea, Oradea, Romania; Recruiting
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Otilia Labau, Dr., Principal Investigator

Emergency Clinical County Hospital Tg. Mures, Tg. Mures, Romania; Recruiting
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Galafteon Oltean, Prof. Dr., Principal Investigator

Emergency Clinical City Hospital Timisoara, Timisoara, Romania; Recruiting
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Hortensia Ionita, Prof. Dr., Principal Investigator

Emergency Clinical City Hospital Timisoara, Timisoara, Romania; Recruiting
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Liviu Cheveresan, Dr., Principal Investigator

Oncomed SRL, Timisoara, Romania; Recruiting
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Rodica Mihaescu, Dr., Principal Investigator

Salvo-San-Ciobanca SRL, Zalau, Romania; Recruiting
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Claudia Simona Nicorici Fekete, Dr., Principal Investigator

Clinical Hospital Bezanijska Kosa, Belgrade, Serbia; Recruiting
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Dragomir Marisavljevic, Prof. Dr., Principal Investigator

Clinical Center of Serbia, Belgrade, Serbia; Recruiting
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Nada Suvajdzic Vukovic, Prof. Dr., Principal Investigator

Clinical Center Kragujevac, Kragujevac, Serbia; Recruiting
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Predag Djurdjevic, Assoc. Prof., Principal Investigator

Clinical Center Nis, Nis, Serbia; Recruiting
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Ivan Tijanić, Prof. Dr., Principal Investigator

Additional Information

Starting date: November 2011
Last updated: January 30, 2013

Page last updated: February 07, 2013

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