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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01390649
Recruitment Status : Completed
First Posted : July 11, 2011
Results First Posted : October 19, 2015
Last Update Posted : April 8, 2016
Information provided by (Responsible Party):
CSL Behring

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.

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenic Purpura Biological: IgPro10 Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2011
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
Experimental: IgPro10 Biological: IgPro10
IgPro10 will be administrated by IV infusion either a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first treatment.
Other Name: Privigen

Primary Outcome Measures :
  1. Set of Antibodies Most Frequently Bound to Red Blood Cells (RBCs) in Subjects Experiencing Clinically Significant Intravascular Hemolysis [ Time Frame: 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 :
  1. Responder Rate [ Time Frame: 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01390649

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UMHAT "Dr. Georgi Stranski" Clinic of Haematology
Pleven, Bulgaria
UMHAT "Sv. Georgi" Clinic of Haematology
Plovdiv, Bulgaria
Tokuda Hospital
Sofia, Bulgaria
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 Nis
Nis, Serbia
Sponsors and Collaborators
CSL Behring
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Principal Investigator: Wieslaw Jedrzejczak Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie

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Responsible Party: CSL Behring Identifier: NCT01390649     History of Changes
Other Study ID Numbers: IgPro10_4001
2011-000263-27 ( EudraCT Number )
First Posted: July 11, 2011    Key Record Dates
Results First Posted: October 19, 2015
Last Update Posted: April 8, 2016
Last Verified: September 2015
Keywords provided by CSL Behring:
Additional relevant MeSH terms:
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Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs