EUCTR2011-006294-26-ES进行中（未招募）不适用
A Phase 3, Prospective, Open-label, Randomized Study to Evaluate Safety and Efficacy of Recombinant Activated FVII BI (rFVIIa BI) in the Treatment of Acute Bleeding Episodes per an On-demand Regimen in Patients with Hemophilia A or B with Inhibitors - rFVIIa BI Treatment of Acute Bleeding Episodes per an On-demand Regimen
适应症
试验速览
- 阶段
- 不适用
- 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
- Male
入选标准
- •? Subject is male with hemophilia A or B with inhibitors, with a high titer (?5 BU) or a historical high anamnestic response.
- •? Subject is 12 to 65 years old at the time of screening.
- •? Subject is currently using or has used bypassing agents for treatment of bleeding episodes.
- •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 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •? Subject has a known hypersensitivity to rFVIIa, hamster or murine
- •proteins, or Tween 80.
- •? Subject has a prior history of thromboembolic event
- •? Subject is positive for a FVII inhibitor at screening
研究者
相似试验
进行中（未招募）
不适用
A Phase 3, Prospective, Open-label, Randomized Study to Evaluate Safety and Efficacy of Recombinant Activated FVII BI in the Treatment of Acute Bleeding Episodes per an On-demand Regimen in Patients with Hemophilia A or B with InhibitorsHemophilia A or B with FVIII or FIX inhibitorsMedDRA version: 14.1Level: LLTClassification code 10053751Term: Hemophilia A with anti factor VIIISystem Organ Class: 100000004850MedDRA version: 14.1Level: LLTClassification code 10053752Term: Hemophilia B with anti factor IXSystem Organ Class: 100000004850EUCTR2011-006294-26-PLBaxter Innovations GmbH50
进行中（未招募）
不适用
A Phase 3, Prospective, Open-label, Randomized Study to Evaluate Safety and Efficacy of Recombinant Activated FVII BI in the Treatment of Acute Bleeding Episodes per an On-Demand Regimen in Patients with Hemophilia A or B with InhibitorsHemophilia A or B with FVIII or FIX inhibitorsMedDRA version: 14.1Level: LLTClassification code 10053751Term: Hemophilia A with anti factor VIIISystem Organ Class: 100000004850MedDRA version: 14.1Level: LLTClassification code 10053752Term: Hemophilia B with anti factor IXSystem Organ Class: 100000004850EUCTR2011-006294-26-BEBaxter Innovations GmbH36
招募中
1 期
A Study of an Intermittent ADT Approach with Apalutamide Monotherapy in Participants with mCSPCMetastatic Castration-Sensitive Prostate Cancer (mCSPC)CTIS2022-502686-24-00Janssen - Cilag International246
进行中（未招募）
1 期
rsodeoxycholic Acid (UDCA) in Preventing Hepatobiliary and Colorectal Malignancy in Surveillance Patients with Primary Sclerosing Cholangitis (PSC)Primary sclerosing cholangitis with or without concomitant inflammatory bowel disease included in an unlimited surveillance program for hepatobiliary and colorectal malignancyEUCTR2015-003310-24-SESahlgrenska Academy500
已完成
3 期
linastatin for COVID-19 in patients with breathlessnessCTRI/2020/06/025704Bharat Serums and Vaccines ltd