CTRI/2022/05/042825招募中3 期
Open-label Study Investigating Efficacy, Safety and Pharmacokinetics of Concizumab Prophylaxis in Children Below 12 Years With Haemophilia A or B With or Without Inhibitors
ovo Nordisk AS0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
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
入选标准
- •Participants are eligible to be included in the study only if all the following criteria apply:
- •1. Informed consent/assent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- •2. Diagnosis of congenital severe haemophilia A (FVIII <1%) or moderate/severe congenital haemophilia B (FIX =2%), or congenital haemophilia with inhibitors.
- •3. For arm 1 only: Male aged <12 years of age at the time of signing informed consent.
- •4. For arm 1 only: Patients with inhibitors (HAwI or HBwI):
- •a. Patients with HAwI with historical medical records of a total of at least 26 weeks of on-demand treatment within the last 52 weeks prior to enrolment
- •b. Patients with HBwI with historical medical records of a total of at least 26 weeks of on-demand treatment within the last 52 weeks prior to enrolment
- •c. Patients with HBwI regardless of the regimen and duration of previous haemophilia treatment
- •5. For arm 1 only: Patients without inhibitors (HA or HB):
- •a. Patients with historical medical records of at least 52 weeks of on-demand treatment during the last year prior to enrolment and with at least 3 documented treated bleeds during this period
- •b. Patients with historical medical records of a total of at least 26 weeks of PPX treatment within the last 52 weeks prior to enrolment
- •6. For arm 2 only: Male patients (regardless of age) previously treated with concizumab via compassionate use.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •1. Known or suspected hypersensitivity to study intervention or related products.
- •2. Previous participation in this study. Participation is defined as signed informed Consent.
- •3. Participation (i.e., signed informed consent) in any study or programme with investigational
- •drug other than concizumab within 5 half-lives or 30 days before screening, whichever is
- •4. Platelets = 100x109/L at screening.
- •5. Fibrinogen below laboratory lower normal limit at screening.
- •6. Hepatic dysfunction defined as AST and/or ALT >3 times the upper limit combined with total
- •bilirubin >1.5 times the upper limit at screening.
- •7. Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) =30 ml/min/1.73 m2 calculated from serum creatinine measured at screening.
- •8. Known inherited or acquired coagulation disorder other than congenital haemophilia.
- •History of thromboembolic diseasea. Current clinical signs of or treatment for thromboembolic
- •disease. Patients who in the judgement of the investigator are considered at high risk of
- •thromboembolic events.
- •10. A known systemic inflammatory condition requiring systemic treatment at screening.
- •11. Treatment with emicizumab within 180 days before treatment with concizumab.
- •12. Ongoing or planned Immune Tolerance Induction treatment.
- •13. Any disorder, except for conditions associated with haemophilia, which in the investigator’s
- •opinion might jeopardise participant’s safety or compliance with the protocol.
研究者
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