NCT01968655No Longer Available不适用
Expanded Access to B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies
Baxalta now part of Shire4 个研究点 分布在 1 个国家开始时间: 2013年10月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
- 试验地点
- 4
研究概览
简要总结
To provide emergency access to OBI-1 for patients with Acquired Hemophilia and a serious bleeding episode who do not have access to an active clinical study site associated with the OBI-1-301 study.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent from participant or their legal representative.
- •Participants with acquired hemophilia with autoimmune inhibitors to human factor VIII.
- •Has a serious bleeding episode, as documented by the investigator.
- •Be willing and able to follow all instructions and attend all study visits.
- •Participants taking anti-thrombotics may be included depending on the time elapsed since taking such medications.
- •Life expectancy of at least 90 days prior to the onset of the bleeding episode.
排除标准
- •Hemodynamically unstable after blood transfusion, fluid resuscitation and pharmacologic or volume replacement pressor therapy.
- •Has an established reason for bleeding that is not correctable.
- •Bleeding episode assessed likely to resolve on its own if left untreated.
- •Anti-OBI-1 inhibitor that exceeds 20 BU (prospectively or retrospectively).
- •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 "new" qualifying bleeding episodes.
- •Prior history of bleeding disorder other than acquired hemophilia.
- •Known major sensitivity (anaphylactoid reactions) to pig or hamster products.
- •Use of hemophilia medication within 3 to 6 (depending on medication) hours prior to OBI-1 administration.
- •Participation in any other clinical study within 30 days of the first OBI 1 treatment.
- •Anticipated need for treatment or device during the study that may interfere with the evaluation.
- •Abnormal baseline findings
- •Inability or unwillingness to comply with the study design, protocol requirements, or the follow-up procedures.
研究者
研究点 (4)
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