CTRI/2012/03/002487已完成2 期
Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies - Nil
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
入排标准
入选标准
- •1)Males or females >=18 years of age.
- •2) Written informed consent from subject, trusted person or person who is legally authorized to sign on behalf of the subject (Legal Representative in U.S.), depending on local regulations
- •3) Subjects with acquired hemophilia with autoimmune inhibitors to human factor VIII, with a clinical diagnosis established by the following criteria:
- •a) Prolonged activated partial thromboplastin time (aPTT)
- •b) Prothrombin time (PT) <=ULN + 2 seconds and platelet count within normal range.
- •c) Abnormal aPTT mixing study (patient-normal control 1:1) consistent with a factor VIII inhibitor
- •d) Reduced factor VIII activity level (below 10%)
- •4) Has a serious bleeding episode, as documented by the investigator
- •5) Be willing and able to follow all instructions and attend all study visits.
- •6) Subjects taking anti-thrombotics (such as clopidogrel, heparin or heparin analogue) may be included provided three half lives have elapsed since the last dose of the agent.
- •7) Life expectancy of at least 90 days prior to the onset of the bleeding episode.
- •8) Subjects of reproductive age must use acceptable methods of contraception and if female, undergo pregnancy testing as part of the screening process.
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).
- •Exclusion Criteria:
- •2) Has an established reason for bleeding that is not correctable.
- •3) Bleeding episode assessed likely to resolve on its own if left untreated.
- •4) Anti-OBI-1 inhibitor that exceeds 20 BU (prospectively or retrospectively)
- •5) Subsequent bleeding episode at the site of the initial qualifying bleeding episode within 2 weeks following the final OBI-1 dose for the initial qualifying bleeding episode, or subsequent bleeding episode at a different site than the initial qualifying bleeding episode within 1 week following the final OBI-1 dose for the initial qualifying bleeding episode will not be considered â??newâ?? qualifying bleeding episodes.
- •Prior history of bleeding disorder other than acquired hemophilia.
- •7) 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®)
- •8) Use of hemophilia medication: rFVIIa within 3 hours prior to OBI-1 administration, or aPCC treatment within 6 hours prior to OBI-1 administration.
- •9) Participation in any other clinical study within 30 days of the first OBI-1 treatment.
- •10) Anticipated need for treatment or device during the study that may interfere with the evaluation of the safety or efficacy of OBI-1, or whose safety or efficacy may be affected by OBI-1.
- •11) Is currently pregnant or breastfeeding, or planning to become pregnant or father a child during the study.
- •12) Abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subjectâ??s safety or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
- •13) Inability or unwillingness to comply with the study design, protocol requirements, or the follow-up procedures.
- •14) Patient of majority age under legal protection.
研究者
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