EUCTR2011-000263-27-BG进行中（未招募）不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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;
- •IgA levels below the detection limit
- •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 of 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).
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