EUCTR2011-001899-18-GB进行中（未招募）1 期
Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Patients with Congenital Hemophilia A With Factor VIII Inhibitors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 28
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
- •1) Males or females = 6 years of age.
- •2) Written informed consent from subject or subject’s legal representative.
- •3) Subjects with congenital hemophilia A with a human factor VIII inhibitor =30 BU assessed within 30 days prior to study entry and no documented human factor VIII inhibitor >30 BU within the prior 90 days..
- •4) Has previously or is currently demonstrating suboptimal hemostatic response to bypassing agents for treatment of bleeding episodes; suboptimal response is determined by the investigator, but minimally includes no or minimal evidence of response after at least two doses of bypassing agents, either for the current or a historic bleeding episode.
- •5) Has an anti-OBI-1 titer =10 BU.
- •6) Has any serious or life-threatening bleeding episode; or requires a major or minor surgical procedure that could lead to a serious bleeding episode if not well controlled.
- •7) Is willing and able to follow all instructions and attend all study visits.
- •8) Has no other significant hemostatic abnormality and:
- •a) Platelets >100,000/mm^3
- •b) Prothrombin time <15 seconds
- •c) INR =1.3
- •9) Subjects taking anti-thrombotics (such as clopidogrel, heparin or heparin analogue) may be included provided three half-lives of the agent have elapsed since the last dose of the agent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 18
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 9
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1) Hemodynamically unstable after blood transfusion, fluid resuscitation and pharmacologic or volume replacement pressor therapy. This hemodynamic instability is characterized by symptomatic hypotension resulting in vital organ dysfunction, such as cardiac ischemia, oliguria (urine volume <0.5 mL/kg in the previous six hours), central nervous system hypoperfusion manifested by mental status change such as confusion (unless head injury or intracranial hemorrhage is present), pulmonary compromise, and/or acidosis (manifested by pH and lactate levels).
- •2) Bleeding episode assessed likely to resolve on its own if left untreated.
- •3) Prior history of bleeding disorder other than congenital hemophilia A.
- •4) Known major sensitivity (anaphylactoid reactions) to therapeutic products of porcine or hamster origin; examples include therapeutics of porcine origin (e.g. previously marketed porcine factor VIII, Hyate-C®) and recombinant therapeutics prepared from hamster cells (e.g. Humira®, Advate® and Enbrel®).
- •5) Received any other investigational treatment within 30 days of the first OBI-1 treatment.
- •6) Anticipated need for treatment or device during the study that may interfere with the evaluation of the safety or efficacy of OBI-1, whose safety or efficacy may be affected by OBI-1.
- •7) Is planning to father a child during the study.
- •8) Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subject’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
- •9) Inability or unwillingness to comply with the study design, protocol requirements, or the follow-up procedures.
研究者
相似试验
已完成
2 期
Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Acquired Hemophilia ACTRI/2012/03/002487Baxter Innovations GmbH28
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Study of a new factor VIII replacement for patients with acquired hemophilia AAcquired Haemophilia AMedDRA version: 16.0Level: LLTClassification code 10053761Term: Acquired hemophilia with anti FVIII, XI, or XIIISystem Organ Class: 100000004851EUCTR2011-000181-34-DEBaxter Innovations GmbH28
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Study of a new factor VIII replacement for patients with acquired hemophilia AAcquired Haemophilia AMedDRA version: 16.0Level: LLTClassification code 10053761Term: Acquired hemophilia with anti FVIII, XI, or XIIISystem Organ Class: 100000004851EUCTR2011-000181-34-HUBaxter Innovations GmbH28
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Study of a new factor VIII replacement for patients with acquired hemophilia AAcquired Haemophilia AMedDRA version: 14.1Level: LLTClassification code 10053761Term: Acquired hemophilia with anti FVIII, XI, or XIIISystem Organ Class: 100000004851EUCTR2011-000181-34-GBBaxter Innovations GmbH28