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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 3 November 2014
Main ID:  EUCTR2011-000263-27-PL
Date of registration: 08/06/2011
Prospective Registration: Yes
Primary sponsor: CSL Behring LLC
Public title: An non-blinded, mulicenter study to investigate the mechanisms which are involved in the interaction of red blood cells with the study drug IgPro10 in patients with chronic immune thrombocytopenic purpura (ITP) who have shown signs of hemolysis (a breakdown or destruction of red blood cells).
Scientific 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. - Privigen® in ITP
Date of first enrolment: 22/07/2011
Target sample size: 150
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000263-27
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no  
Phase: 
Countries of recruitment
Bulgaria Poland Serbia Turkey
Contacts
Name: (Babette von Hagen) Senior CRA   
Address:  Emil-von-Behring-Straße 76 35041 Marburg Germany
Telephone: 496421396763
Email: babette.vonhagen@cslbehring.com
Affiliation:  CSL Behring GmbH
Name: (Babette von Hagen) Senior CRA   
Address:  Emil-von-Behring-Straße 76 35041 Marburg Germany
Telephone: 496421396763
Email: babette.vonhagen@cslbehring.com
Affiliation:  CSL Behring GmbH
Key inclusion & exclusion criteria
Inclusion criteria:
• Diagnosis of chronic ITP defined by:
?- Failure to find other causes of thrombocytopenia,
?- Platelet count of = 150 x 109/L over 6 months or response to a previous treatment with subsequent decrease in platelet count even if duration of chronic ITP is less than 6 months;
• Age of 18 to 65 years;
• Platelet count of = 30 x 109/L at screening;
• Written informed consent for study participation obtained before undergoing any study specific procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• Planned splenectomy throughout the study period;
• Treatment with IVIG or anti-D immunoglobulin within 3 weeks prior to screening;
• Drugs that have any pharmacological effect on the blood clotting system within 3 weeks prior to screening
(i.e., clotting factors, heparin, coumarin derivates, acetylsalicylic acid in high dose, and thrombopoietin receptor agonists [e.g., eltrombopag and romiplostim]);
• Known allergic or other severe reactions to blood products including intolerability to previous IVIG (i.e. aseptic meningitis, recurrent severe headache, hypersensitivity, intravascular hemolysis);
• Known hyperprolinemia;
• Abnormal results in the following laboratory parameters at screening:
?- Hemoglobin < 11 g/dL,
?- Positive DAT,
?- Indirect bilirubin > the upper limit of the normal range (ULN),
?- Serum free haptoglobin < 0.2 g/L,
?- LDH > ULN,
?- Alanine aminotransferase (ALAT) > 2.5 x ULN,
-? Aspartate aminotransferase (ASAT) > 2.5 x ULN,
?- Creatinine > 1.5 x ULN,
?- Reticulocyte count > 1.5 x ULN,
?- Iron < 50% of LLN, ferritin < 50 LLN, vitamin B12 < 50% of LLN;
• Pregnancy, lactation, or planned pregnancy;
• RBC transfusion or erythropoietin treatment within the last 14 days;
• One of the following concomitant diseases:
-? Clinically active systemic lupus erythematosus,
?- Known or suspected HIV infection,
?- Acute hepatitis,
-? Clinically active chronic hepatitis,
-? Lymphoproliferative disease,
?- Sickle cell disease,
??- New York Heart Association (NYHA) grade III or IV heart failure;
• Febrile illness or acute infection between screening and Day 1 (to be checked on Day 1 prior to dosing);
• Body temperature = 38°C at screening or prior to treatment on Day 1 (to be checked on Day 1 prior to dosing);
• History of Evan’s syndrome;
• Participation in another clinical study during the last 3 months;
• Alcohol, drug, or medication abuse within one year before the study;
• Re-entry of subjects previously treated in the present study;
• Re-screening within 4 weeks after the preceding screening;
• Suspected inability (e.g., language problems) or unwillingness to comply with study procedures;
• Mental condition rendering the subject (or the subject’s legally acceptable representative[s]) unable to
understand the nature, scope and possible consequences of the study) ;
• Any condition that is likely to interfere with evaluation of the IMP or satisfactory conduct of the study;
• Employee at the study site, or spouse/partner or relative of any study staff (e.g., investigator, sub-investigators, or study nurse).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Chronic immune thrombocytopenic purpura (ITP)
MedDRA version: 15.0 Level: PT Classification code 10021245 Term: Idiopathic thrombocytopenic purpura System Organ Class: 10005329 - Blood and lymphatic system disorders
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Intervention(s)

Trade Name: Privigen®
Product Name: Privigen®
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Human Normal Immunoglobulin G (IgG > 98% purity)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Concentration unit: % percent
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)
Main Objective: The primary objective of this study is to investigate the specificity of in vivo antibody binding to red blood cells
(RBCs) in 10 subjects with chronic ITP who have shown signs of hemolysis and who experience clinically
significant intravascular hemolytic reactions following treatment with IgPro10. The study will explore potential
mechanisms of hemolysis by analysis of the specificity of the antibodies possibly involved.
Primary end point(s): The primary endpoint is the set of antibodies most frequently bound to RBCs in subjects experiencing clinically significant intravascular hemolysis. The presumptive hemolysis cases will be adjudicated by an independent Adjudication Committee to determine if the hemolysis represents clinically significant intravascular hemolysis. Most frequent antibodies are defined as those antibodies that are identified at day 3 as binding specific red cell antigens (determined using an antigen panel) in at least 4 subjects (out of 10 with clinically significant hemolysis).
Secondary Objective: The secondary objectives are to assess other safety and efficacy parameters, including the rates of presumptive
hemolytic events and clinically significant intravascular hemolytic reactions.
Timepoint(s) of evaluation of this end point: Continously
Secondary Outcome(s)
Secondary end point(s): Subjects with a platelet response (PR) defined as subjects having a platelet count increases at least once to = 50 x 109/L within 6 days after the first infusion (i.e., up to and including Day 7).
Timepoint(s) of evaluation of this end point: 6 days after the first infusion
Secondary ID(s)
IgPro10_4001
Source(s) of Monetary Support
CSL Behring GmbH
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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