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 40 人开始时间: 2011年9月27日最近更新: 2022年4月4日

试验速览

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•1. Age of at least 18 years and 65 years at maximum.
•2. Confirmed diagnosis of chronic primary ITP (threshold platelet count less than 100x10 exp9/L) of at least 12 months duration
•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 75
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•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