CTIS2022-502542-28-00进行中（未招募）1 期
A RANDOMIZED DOUBLE-BLIND PHASE IIA STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB AS ADJUNCT TREATMENT IN PREVENTION OF VASO-OCCLUSIVE EPISODES (VOE) IN SICKLE CELL DISEASE (SCD) - BO42451
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 97
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 64（—）
- 性别
- All
入选标准
- •Body weight >=40 kg, Male or female with confirmed diagnosis of HbSS (SCD genotype of sickle cell anemia) or HbSß0 (SCD genotype of sickle cell beta zero thalassemia), Two or more (>=2) to <=10 documented VOEs in the 12 months prior to randomisation, If receiving concurrent SCD-directed therapy, the participant must have been on a stable dose for a minimum of 3 months prior to study enrollment. There should be no plans to modify the participants' dosing throughout the study duration, other than for safety reasons, Vaccination against N. meningitides serotypes A, C, W, and Y, and vaccinations against H. influenza type B and S. pneumonia, Adequate hepatic and renal function
排除标准
- •History of hematopoietic stem cell transplant, Participating in a chronic transfusion program and/or planning on undergoing an exchange transfusion during the duration of the study, History of hypersensitivity, allergic, or anaphylactic reactions to any ingredient contained in the study treatment, Hemoglobin <6 g/dL, Active systemic bacterial, viral, or fungal infection within 14 days before first drug administration, Presence of fever (>=38 degrees Celsius) within 7 days before the first drug administration
研究者
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