EUCTR2016-000072-17-GB进行中（未招募）1 期
A RANDOMIZED, MULTICENTER, OPEN-LABEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PROPHYLACTIC EMICIZUMAB VERSUS NO PROPHYLAXIS IN HEMOPHILIA A PATIENTS WITHOUT 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
- 152
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
- •- Aged 12 years or older at the time of informed consent
- •- Body weight >= 40 kg at the time of screening
- •- Diagnosis of severe congenital haemophilia A (intrinsic FVIII level < 1%)
- •- A negative test for inhibitor (i.e., < 0.6 Bethesda units [BU]) within 8 weeks of enrollment
- •- No documented inhibitor (i.e., < 0.6 BU), FVIII half-life < 6 hours, or FVIII recovery < 66% in the last 5 years
- •- Patients who completed successful immune tolerance induction (ITI) at least 5 years before screening are eligible, provided they have had no evidence of inhibitor recurrence (permanent or temporary) as may be indicated by detection of an inhibitor, FVIII half-life < 6 hrs, or FVIII recovery < 66% since completing ITI
- •- Documentation of the details of prophylactic or episodic FVIII treatment and of number of bleeding episodes for at least the last 24 weeks
- •- For patients on no prophylaxis (episodic treatment) pre-study, >= 5 bleeds in the last 24 weeks prior to study entry
- •- Patients who were on FVIII prophylaxis for at least the last 24 weeks, can be enrolled regardless of the number of bleeds during this period. Eligibility will be based on investigator’s attestation of adequate prophylaxis regimen.
- •- At least 40 patients who were on FVIII prophylaxis pre-enrolment will have been enrolled for minimum of 24 weeks in Study BH29768 (non-interventional)
- •- Adequate haematologic function, defined as platelet count >= 100,000/ microliter and haemoglobin >= 8 gram/decilitre (4.97 millimoles/liter) at the time of screening
- •- Adequate hepatic and renal function
- •- Agreement to remain abstinent or use contraceptive methods specified in the study
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 12
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 128
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •- Inherited or acquired bleeding disorder other than haemophilia A
- •- Previous (in the past 12 months) or current treatment for thromboembolic disease (except previous catheter-associated thrombosis for which anti thrombotic treatment is not currently ongoing) or signs of thromboembolic disease
- •- Other conditions (e.g., certain autoimmune diseases) that may increase risk of bleeding or thrombosis
- •- Known human immunodeficiency virus infection with CD4 count < 200 cells/microlitre within 24 weeks prior to screening
- •- Use of systemic immunomodulators at enrolment or planned use during the study (except anti-retroviral therapy)
- •- Patients who are at high risk for thrombotic microangiopathy (e.g., have a previous medical or family
- •history of TMA), in the investigator’s judgment
- •- Receipt of emicizumab in a prior investigational study, an investigational drug to treat or reduce the risk of haemophilic bleeds within 5 half-lives of last drug administration, and a non-haemophilia-related investigational drug concurrently, within last 30 days or 5 half-lives, whichever is shorter
- •- Pregnant or lactating, or intending to become pregnant during the study
- •- Women who are not postmenopausal (>=48 weeks of non-therapy-induced amenorrhea) or surgically sterile must have a negative pregnancy test result within 7 days prior to initiation of study drug
研究者
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