2025-523660-21-00招募中3 期
C0371017 - A PHASE 3, NON-INVESTIGATIONAL PRODUCT, MULTI COUNTRY COHORT STUDY TO DESCRIBE THE LONG-TERM SAFETY AND EFFECTIVENESS OF A PRIOR SINGLE-DOSE TREATMENT WITH INVESTIGATIVE GIROCTOCOGENE FITELPARVOVEC OR FIDANACOGENE ELAPARVOVEC IN PARTICIPANTS WITH HEMOPHILIA A OR HEMOPHILIA B, RESPECTIVELY
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Pfizer Inc.
- 入组人数
- 32
- 试验地点
- 12
- 主要终点
- Incidence of factor inhibitor development
研究概览
简要总结
To characterize the long-term safety of participants who have received prior treatment with giroctocogene fitelparvovec or fidanacogene elaparvovec To describe durability of transgene expression of giroctocogene fitelparvovec or fidanacogene elaparvovec
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Only participants who received giroctocogene fitelparvovec or fidanacogene elaparvovec and were enrolled in a Pfizer-sponsored study are eligible.
排除标准
- 未提供
研究组 & 干预措施
fidanacogene elaparvovec
Test
干预措施: fidanacogene elaparvovec (Drug)
giroctocogene fitelparvovec
Test
干预措施: giroctocogene fitelparvovec (Drug)
结局指标
主要结局
Incidence of factor inhibitor development
Incidence of factor inhibitor development
Incidence of hepatic malignancy
Incidence of hepatic malignancy
Incidence of liver abnormalities
Incidence of liver abnormalities
Factor activity level
Factor activity level
Incidence of thromboembolic events
Incidence of thromboembolic events
次要结局
- Total ABR (treated and untreated)
- EQ-5D-5L dimension and VAS scores
- Incidence of and time from previously administered gene therapy infusion to resumption of prophylaxis
- AIR of exogenous factor
- Consumption of exogenous factor
- Incidence of Non-hepatic malignancy
- Incidence of Auto-immune disorders
- Incidence of SAEs
- All cause-mortality
研究者
Clinical Medical Lead
Scientific
Pfizer Inc.
研究点 (12)
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