EUCTR2020-004839-25-NL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)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
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
- •- Signed ICF or Assent Form (as determined by patient’s age and individual site and country standards)
- •- Age >=12 to <=55 years
- •- 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 randomization
- •- If receiving concurrent SCD-directed therapy, the patient 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 patients’ dosing throughout the study duration, other than for safety reasons.
- •- If receiving erythropoietin, the patient must have been prescribed this medication for the preceding 3 months and be dose-stabilized for at least 3 months prior to study enrollment
- •- Vaccination against N. meningitides serotypes A, C, W and Y
- •- Vaccinations against H. influenza type B and S. pneumonia
- •- Patients who have been vaccinated (partially or in full) against SARS-CoV-2 with a locally approved vaccine are eligible to be enrolled in the study, 3 days or longer after inoculation
- •- Adequate hepatic and renal function
- •- For women of childbearing potential, agreement to remain abstinent or use contraception during the treatment period and for 46 weeks (approximately 10.5 months) after the final dose of study treatment
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 23
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 67
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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
- •- Received active treatment on another investigational trial within 28 days (or within five half-lives of that agent, whichever is greater) prior to screening visit, or plans to participate in another investigational drug trial
- •- Hemoglobin <6 g/dL
- •- Known or suspected hereditary complement deficiency
- •- 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
- •- Immunized with a live attenuated vaccine within 1 month before first drug administration
- •- Pregnant or breastfeeding, or intending to become pregnant during the study or within 46 weeks (approximately 10.5 months) after the final dose of study treatment
- •- Known HIV infection with documented CD4 count <200 cells/microliter within 24 weeks prior to screening
- •- History of N. meningitidis infection within the prior 6 months
研究者
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