ISRCTN37539930已完成3 期
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
Octapharma AG (Switzerland)0 个研究点目标入组 95 人开始时间: 2013年2月27日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 95
研究概览
简要总结
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30687970 (added 10/04/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age of >=18 years years and <=65 years
- •2. Confirmed diagnosis of chronic primary ITP of at least 12 months duration (diagnosed with threshold platelet count less than 100x109/L)
- •3. Platelet count of <=20x10exp9/L with or without bleeding manifestations
排除标准
- •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
- •3. Unresponsive to previous treatment with IGIV or anti-D immunoglobulin.
- •4. Severe liver or kidney disease (alanine aminotransferase [ALAT] 3x > upper limit of normal, creatinine >120 µmol/L).
- •5. Patients with risk factors for thromboembolic events in whom the risks outweigh the potential benefit of NewGam treatment.
研究者
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