EUCTR2019-002179-32-FR进行中（未招募）1 期
A MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, EFFICACY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF EMICIZUMAB IN PATIENTS WITH MILD OR MODERATE HEMOPHILIA A WITHOUT FVIII INHIBITORS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •Diagnosis of mild (FVIII level between > 5% and < 40%) or moderate (FVIII level between >= 1% and <= 5%) congenital Hemophilia A without FVIII inhibitors
- •- Weight >= 3 kg
- •- Need for prophylaxis based on investigator assessment
- •- A negative test for inhibitor (i.e., < 0.6 BU/mL) within 8 weeks prior to enrollment
- •- No documented inhibitor (i.e., < 0.6 BU/mL), FVIII half-life < 6 hours, or FVIII recovery < 66% in the last 5 years
- •- Documentation of the details of prophylactic or episodic FVIII treatment and of number of bleeding episodes for at least the last 24 weeks prior to enrollment
- •- Adequate hematologic hepatic and renal function
- •- For women of childbearing potential: agreement to remain abstinent or use contraception during the treatment period and for at least 24 weeks after the final dose of study drug
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Inherited or acquired bleeding disorder other than mild (FVIII level between > 5% and < 40%) or moderate (FVIII level between >= 1% and <= 5%) congenital hemophilia A
- •- History of illicit drug or alcohol abuse within 48 weeks prior to screening, in the investigator’s judgment
- •- Previous (within the last 12 months) or current treatment for thromboembolic disease or signs of thromboembolic disease
- •- Other conditions that may currently increase the risk of bleeding or thrombosis
- •- History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection
- •- Planned surgery during the emicizumab loading dose phase Surgeries in patients on emicizumab from Week 5 onwards are allowed
- •- Known HIV infection with CD4 counts < 200 cells/micro L
- •- Concomitant disease, condition, significant abnormality on screening evaluation or laboratory tests, or treatment that could interfere with the conduct of the study, or that would in the opinion of the investigator, pose an additional unacceptable risk in administering study drug to the patient
- •- Receipt of any of the following:
- •o An investigational drug to treat or reduce the risk of hemophilic bleeds within 5 half-lives of last drug administration with the exception of prior emicizumab prophylaxis
- •o A non-hemophilia-related investigational drug within last 30 days or 5 half-lives, whichever is shorter
- •o Any other investigational drug currently being administered or planned to be administered
- •- Inability to comply with the study protocol in the opinion of the investigator
- •- Pregnant or breastfeeding, or intending to become pregnant during the study
- •- Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study drug
研究者
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