Prospective, open-label, non-controlled, multicenter, phase III clinical study to evaluate the efficacy and safety of Octagam 10% in Primary Immune Thrombocytopenia

Octapharma AG (Switzerland)0 个研究点目标入组 30 人开始时间: 2012年7月12日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Age of >=18 years and <=65 years
•2. Confirmed diagnosis of chronic primary ITP (threshold PC less than 100x10^9/L) of at least 12 months duration
•3. Platelet count of <30x10^9/L with or without bleeding manifestations

•1. Thrombocytopenia secondary to other diseases (such as AIDS or SLE) or drug-related thrombocytopenia
•2. Administration of IVIG, anti-D or thrombopoietin receptor agonists or other platelet enhancing drugs (including immunosuppressive or other immunomodulatory drugs) within 3 weeks before enrolment
•3. Unresponsive to previous treatment with IVIG or anti-D immunoglobulin
•4. Severe liver or kidney disease (ALAT 3x > upper limit of normal, creatinine >120 µmol/L)
•5. Patients with risk factors for TEEs in whom the risks outweigh the potential benefit of Octagam treatment

发起方

Octapharma AG (Switzerland)