JPRN-jRCT2041220046招募中3 期
AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF MARSTACIMAB PROPHYLAXIS IN PARTICIPANTS WITH SEVERE HEMOPHILIA A AND B WITH OR WITHOUT INHIBITORS
Kawai Norisuke0 个研究点目标入组 145 人开始时间: 2022年7月29日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 145
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
- >= 12age old 至 <= 74age old（—）
- 性别
- Male
入选标准
- •Inclusion Criteria:
- •*All participants will have a minimum body weight of 35 kg
- •*Participants have successfully completed participation in study B7841005, defined as did not require Early Termination from study B7841005
排除标准
- •Exclusion Criteria:
- •*Previous or current treatment for or history of coronary artery disease, venous or arterial thrombosis (CTCAE Grade >3), or ischemic disease (except catheter-associated thrombosis)
- •*Abnormal renal function as defined by eGFR <30 mL.min/1.73 m(2)
- •*Known planned surgical procedure during the planned study period
- •*Unstable hepatic function as determined by the Investigator clinical assessment and review of the participant's most recent laboratory results, which would make the participant inappropriate for the study
- •*For participants known to be HIV+, worsening disease status as determined by the Investigator clinical assessment and review of participant's most recent laboratory results, to include recent locally available CD4 count (if available), which would make the participant inappropriate for the study
- •*Regular, concomitant therapy with immunomodulatory drugs (eg, IVIG, and routine systemic corticosteroids, rituximab)
- •*Ongoing or planned use of immune tolerance induction or prophylaxis with FVIII or FIX replacement during the study
- •*Participation in other study involving investigational drug(s) or investigational vaccine(s) within 30 days or 5 half-lives prior to or during study participation, with the exception of participation in study B7841005
- •*Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the Investigator, and their respective family members
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