JPRN-jRCT2031210209进行中（未招募）1 期
An Open-Label, Single-Dose, Phase 1/2 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Human Protein C (TAK-662) for the Treatment of Congenital Protein C Deficiency in Japanese Subjects Followed by an Extension Part
ishizawa Atsushi0 个研究点目标入组 5 人开始时间: 2021年7月28日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 5
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
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Male and female participants with Japanese nationality.
- •2. A diagnosis of congenital protein C deficiency (homozygous or compound heterozygous).
- •3. Asymptomatic participant.
- •4. Oral anticoagulants allowed to be received.
- •Extension part:
- •1. Participants who participated in the PK part of this study (TAK-662-1501).
- •2. Participant who are; a. Diagnosed with purpura fulminans (PF), coumarin-induced skin necrosis (CISN)/ warfarin-induced skin necrosis (WISN), and/or other acute thromboembolic episode for on-demand treatment only; b. Requiring treatment with TAK-662 for short-term prophylaxis for surgical procedures; c. Requiring treatment with TAK-662 for long-term prophylaxis.
排除标准
- •1. Current or recurrent disease that could affect the action, or disposition of the investigational product (IP), or clinical or laboratory assessments.
- •2. A body weight less than 8 kg.
- •3. Serious liver dysfunction, judged by the investigator.
- •4. Any thrombosis within 2 weeks prior to administration of the IP.
- •5. Other investigational product than TAK-662 received within 60 days prior to the administration of the IP.
- •6. Current or relevant history of physical or psychiatric illness, or any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the IP or procedures.
- •7. Current use of any medication (including over-the-counter, herbal, or homeopathic preparations) that could affect (improve or worsen) the condition being studied, or could affect the action or disposition of the IP, or clinical or laboratory assessment.
- •8. Known or suspected intolerance or hypersensitivity to the IP, closely-related compounds, or any of the stated ingredients.
- •9. Known history of alcohol or other substance abuse within the last year.
- •10.Within 30 days prior to the first dose of IP, a participant has been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this sponsored study.
- •Extension part:
- •1. New serious medical conditions which could affect participant's safety or treatment were observed during participation in the PK part of this study (TAK-662-1501).
研究者
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