JPRN-jRCT2031220097招募中3 期
Open-label study investigating efficacy, safety and pharmacokinetics ofconcizumab prophylaxis in children below 12 years with haemophilia A or B with or withoutinhibitors(NN7415-4616) - explorer10
Shimizu Yu0 个研究点目标入组 80 人开始时间: 2022年5月28日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
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
- ot applicable 至 < 12age old（—）
- 性别
- Male
入选标准
- •Diagnosis of congenital severe haemophilia A (FVIII <1%) or moderate/severe congenital haemophilia(<=2%), or congenital haemophilia with inhibitors.
- •-For arm 1 only: Male aged <12 years of age at the time of signing informed consent.
- •-For arm 1 only: Patients with historical medical records of a total of at least 26 weeks of treatment within the last 52 weeks prior to enrolmenta
- •-Patients with HAwI with medical records of a total of at least 26 weeks of on demand treatment within the last 52 weeks prior to enrolment.
- •-Patients with HBwI with medical records of a total of at least 26 weeks of on demand treatment within the last 52 weeks prior to enrolment
- •-Patients with HBwI regardless of the regimen and duration of previous haemophilia treatment
- •-Patients without inhibitors with medical records of a total of at least 26 weeks of PPX treatment within the last 52 weeks prior to enrolment
排除标准
- •-Known or suspected hypersensitivity to study intervention or related products.
- •-Previous participation in this study. Participation is defined as signed informed consent.
- •-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
- •-Platelets <=100x109/L at screening.
- •-Fibrinogen below laboratory lower normal limit at screening.
- •-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.
- •-Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) <=30 ml/min/1.73 m2
研究者
相似试验
招募中
1 期
A research study on how well concizumab works for you if you have haemophilia A or B with or without inhibitors (explorer10)CTIS2023-506925-13-00ovo Nordisk A/S135
进行中（未招募）
1 期
A research study on how well concizumab works for you if you have haemophilia A or B with or without inhibitors (explorer10)Haemophilia A with or without inhibitorsHaemophilia B with our without inhibitorsMedDRA version: 20.0Level: LLTClassification code 10053752Term: Hemophilia B with anti factor IXSystem Organ Class: 100000004850MedDRA version: 20.1Level: LLTClassification code 10053754Term: Hemophilia B without inhibitorsSystem Organ Class: 100000004850MedDRA version: 20.0Level: LLTClassification code 10053753Term: Hemophilia A without inhibitorsSystem Organ Class: 100000004850MedDRA version: 20.0Level: LLTClassification code 10053751Term: Hemophilia A with anti factor VIIISystem Organ Class: 100000004850EUCTR2020-000504-11-ITOVO NORDISK. S.P.A.96
进行中（未招募）
1 期
A research study on how well concizumab works for you if you have haemophilia A or B with or without inhibitors (explorer10)Haemophilia A with or without inhibitorsHaemophilia B with our without inhibitorsMedDRA version: 20.0Level: LLTClassification code 10053752Term: Hemophilia B with anti factor IXSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 20.0Level: LLTClassification code 10053751Term: Hemophilia A with anti factor VIIISystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 20.0Level: LLTClassification code 10053753Term: Hemophilia A without inhibitorsSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 20.1Level: LLTClassification code 10053754Term: Hemophilia B without inhibitorsSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2020-000504-11-BGovo Nordisk A/S127
进行中（未招募）
1 期
A research study on how well concizumab works for you if you have haemophilia A or B with or without inhibitors (explorer10)Haemophilia A with or without inhibitorsHaemophilia B with our without inhibitorsMedDRA version: 20.0Level: LLTClassification code 10053752Term: Hemophilia B with anti factor IXSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 20.0Level: LLTClassification code 10053751Term: Hemophilia A with anti factor VIIISystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 20.0Level: LLTClassification code 10053753Term: Hemophilia A without inhibitorsSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 20.1Level: LLTClassification code 10053754Term: Hemophilia B without inhibitorsSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2020-000504-11-SEovo Nordisk A/S127
进行中（未招募）
1 期
A research study on how well concizumab works for you if you have haemophilia A or B with or without inhibitors (explorer10)EUCTR2020-000504-11-PLovo Nordisk A/S127