JPRN-jRCT2051200066已完成2 期
A Phase 2/3, Open-Label, Non-controlled Study to Evaluate the Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (rpFVIII, TAK-672), in the Treatment of Serious Bleeding Episode in Japanese Subjects with Acquired Hemophilia A (AHA)
Koumura Emiko0 个研究点目标入组 5 人开始时间: 2020年10月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
研究概览
简要总结
The results of this study have suggested that treatment with TAK-672 can be well tolerated and effective as a first-line therapy for Japanese patients with AHA who have serious bleeding events.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Male or female Japanese participants of >=18 years of age.
- •2. Participants who (or their legally authorized representatives) have provided his/her written informed consent form prior to any study-related procedures and study product administration.
- •3. Participants with a diagnosis of AHA based on clinical evaluation and supportive local laboratory testing as shown below:
- •- Presentation with spontaneous bleeding without anatomical cause and without prior known bleeding disorder.
- •- Prolonged activated partial thromboplastin time (aPTT) without explanation.
- •- Abnormal aPTT cross mixing test consistent with FVIII inhibitors
- •- Confirmation of a low factor VIII activity ( FVIII:C).
- •- Positive FVIII inhibitor (>=0.6 BU) as measured either in the local or central laboratory
- •4. Participants with a severe bleeding episode which the investigator finds necessary to treat and whose severe bleeding episode meets at least 1 of the following criteria:
- •- Bleeds that pose a threat to a vital organ that could threaten life (e.g. intracranial bleed, or any site that could obstruct the airway).
- •- Bleeds that pose a threat to a vital organ where life is not threatened but the organ function could be impaired (e.g., intraspinal bleed threatening the spinal cord and/or nerve conduction; a continual bleed into the kidney or bladder that could result in an obstructive uropathy, testicular bleed, bleed in and around the eye).
- •- Bleeds requiring a blood transfusion to maintain the Hgb level at above-life or organ threatening levels (e.g. post-surgical, gastro-intestinal, retro-peritoneal, and thigh bleeds).
- •- Intramuscular bleeds where muscle viability and/or neurovascular integrity is significantly compromised or at risk of being compromised.
- •- Intra-articular bleeds impacting a major joint associated with severe pain, swelling and severe loss of joint mobility (reduced >70%) or where a bleed could result in joint destruction (e.g. in and around the femoral head).
- •5. Participants who are taking anti-thrombotics, (including anti-platelet agents and anticoagulants)with confirmatory laboratory testing documenting specific FVIII inhibitor titer and with 3 half-lives of the agent have elapsed since the last dose.
- •6. Participants with expected life expectancies of at least 90 daysprior to the onset of the hemorrhagic episode.
- •7. Participants of reproductive age who have agreed to use acceptable methods of contraception during the study and if female who have agreed to undergo pregnancy testing as part of the screening process.
- •8. Participant who are able to and willing and able to comply with the requirements of the protocol.
排除标准
- •1. Participants with an established reason for bleeding that is not correctable even with hemostatic therapy.
- •2. Participants presenting a bleeding episode that is assessed likely to resolve on its own, even if left untreated.
- •3. Participants with a known major sensitivity (anaphylactoid reactions) to therapeutic products of porcine or hamster origin; examples include therapeutics of porcine origin (e.g. previously marketed porcine FVIII, Hyate: C) and recombinant therapeutics prepared from hamster cells (e.g. Humira, Advate, and Enbrel).
- •4. Participants with the use of hemophilia medication prior to the administration of TAK-672 under one of the following conditions: (1) use of recombinant activated factor VII (rFVIIa) within 3 hours prior to TAK-672 administration (2) use of activated prothrombin complex concentrate (aPCC) within 6 hours prior to TAK-672 administration or (3) use of plasma-derived FX/FVIIa complex concentrate (pd-FX/FVIIa) within 8 hours prior to TAK-672 administration.
- •5. Participants with an anticipated need for treatment or device during the study that may interfere with the evaluation of the safety or efficacy of TAK-672, or whose safety or efficacy may be affected by TAK-672.
- •6. Participants who are currently pregnant or breastfeeding, or planning to become pregnant or father a child during the study
- •7. Participants who have participated in another clinical study and has been exposed to an investigational product or device within 30 days prior to the study enrollment.
- •8. Participants who are scheduled to participate in another non-observational (interventional) clinical study involving an investigational product or device during the course of the study.
- •9. Participants who are unable to or unwilling to comply with the study design, protocol requirements, and/or the follow-up procedures.
- •10. Participants whose majority of age are under legal protection.
- •11. Participants who are an immediate family member, study site employee, or are in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g. spouse, parent, child, sibling) or may consent under duress.
- •12. Participants who are judged by the investigator as being ineligible for any other reason.
研究者
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