Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A

Octapharma AG0 个研究点目标入组 116 人开始时间: 2006年1月16日最近更新: 2013年6月3日

适应症

试验速览

暂无简介。

•- Age of at least 18 years.
•- Diagnosis of ITP according to standard criteria i.e. isolated thrombocytopenia with an otherwise normal peripheral blood smear (bone marrow examination optional), and absence of other causes of thrombocytopenia.
•- Platelet count of 20.000/µL or less with or without bleeding manifestations.
•- Freely given written informed consent from patient.
•- Women of reproductive age: negative result on a pregnancy test (HCG-based assay) and will practice contraception using a method of proven reliabilty for the duration of the study.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- Chronic refractory ITP patients, defined as those who fail to respond to standard treatment (oral corticosteroids and intravenous immunglobulin and anti-D) or require unacceptably high doses of corticosteroids to maintain a safe platelet count.
•- Thrombocytopenia secondary to other diseases (such as AIDS) or drug-related thrombocytopenia.
•- Administration of IGIV, anti-D or other platelet enhancing drugs within 30 days before enrollment, except for long-term corticosteroid therapy in patients with chronic ITP when the dose has been stable during the preceding 30 days and no dosage increase is planned within 7 days after treatment.
•- Experimental treatment (eg Rituximab) within 3 months before enrollment.
•- Prophylactic preoperative treatment for elective splenectomy.
•- Live viral vaccination within the last month before study entry.
•- Emergency operation.
•- Severe liver or kidney disease (ALAT 5x > normal value, creatinine > 120 µmol/L).
•- History of hypersensitivity to blood or plasma derived products, or any component of the product, such as maltose.
•- Known IgA deficiency and antibodies against IgA.
•- History of, or suspected drug abuse.
•- Pregnant and nursing women.
•- Unable or unwilling to comply with the study protocol.
•- Participating in another clinical study currently or during the 3 months before study entry.

发起方