EUCTR2012-005753-23-NL进行中（未招募）1 期
A multicentre study for the long-term follow-up of HLH patients who received treatment with NI-0501, an anti-interferon gamma monoclonal antibody
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Having received at least one dose of NI-0501 during a previous NI-0501 study or under a CU treatment protocol
- •2. Informed Consent by the patient or the patient’s legal representative(s), as applicable, with the assent of patients who are legally capable of providing it
- •3. Having agreed to continue using adequate methods of birth control until 6 months after the last administered dose of NI-0501, whenever relevant. Males with partners(s) of child-bearing potential must agree to take appropriate precautions to avoid fathering a child until 6 months after receiving last dose of NI-0501.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 55
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- 未提供
研究者
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