Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia - NGAM-02

Octapharma AG0 个研究点目标入组 95 人开始时间: 2011年4月12日最近更新: 2015年10月6日

试验速览

暂无简介。

•1. Age of at least 18 years and 65 years at maximum.
•2. Confirmed diagnosis of chronic primary ITP of at least 12 months duration (diagnosed with threshold platelet count less than 100x10 exp9/L)
•3. Platelet count of no more than 20x10exp9/L at with or without bleeding manifestations.
•4. Freely given written informed consent from patient.
•5. Women of childbearing potential must have a negative result on a pregnancy test (human chorionic gonadotropine [HCG]-based assay) and need to practice contraception using a method of proven reliability for the duration of the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 95
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 95
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Thrombocytopenia secondary to other diseases (such as Acquired Immunodeficiency Syndrome [AIDS] or systemic lupus erythematosus [SLE]) or drug-related thrombocytopenia.
•2. Administration of intravenous immunoglobulin (IGIV), anti-D or thrombopoetin receptor agonists or other platelet enhancing drugs (incl. immunosuppressive or other immunomodulatory drugs) within 3 weeks before enrollment, except for:
•a) long-term corticosteroid therapy when the dose has been stable during the preceding 3 weeks and no dosage change is planned until study Day 22.
•b) long-term azathioprine, cyclophosphamide or attenuated androgen therapy when the dose has been stable during the preceding 3 months and no dosage change is planned until study Day 22.
•3. Unresponsive to previous treatment with IGIV or anti-D immunoglobulin.

发起方