CTIS2024-512075-12-00招募中1 期
C3731003 Phase 3, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of PF-07055480 (Recombinant AAV2/6 Human Factor VIII Gene Therapy) in Adult Male Participants with Moderately Severe to Severe Hemophilia A (FVIII:C=1%) - C3731003
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Pfizer Inc.
- 入组人数
- 75
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
- 18 至 64（—）
- 性别
- Male
入选标准
- •Males who have been followed on routine Factor VIII prophylaxis therapy in the lead-in study (C0371004) and have = 150 documented exposure days to a Factor VIII protein product, Moderately severe to severe hemophilia A (Factor VIII activity = 1%), Suspension of FVIII prophylaxis therapy post study drug infusion
排除标准
- •Anti-AAV6 neutralizing antibodies, History of inhibitor to Factor VIII, Laboratory values at screening visit that are abnormal or outside acceptable study limits, Significant and/or unstable liver disease, biliary disease, significant liver fibrosis, Planned surgical procedure requiring Factor VIII surgical prophylactic factor treatment 12 months from screening visit, Active hepatitis B or C, Serological evidence of human immunodeficiency virus HIV-1 or HIV-2 with either Cluster of Differentiation 4 positive (CD4+) cell count =200 mm3 or viral load >20 copies/m
研究者
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