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).

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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