NCT00716716已完成1 期
A Phase I/IIa Safety and Pharmacokinetic Study of Intravenous FIXFc in Previously Treated Hemophilia B Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 6
- 主要终点
- Number of Participants experiencing Adverse Events
研究概览
简要总结
The primary objective of the study is to assess safety of FIXFc at doses ranging from 1 to 100 IU/kg.
详细描述
This study was previously posted by Syntonix Pharmaceuticals, Inc. In January, 2007, sponsorship of the trial was transferred to Biogen Idec. In February, 2017, sponsorship of the trial was transferred to Bioverativ.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Are previously treated (PTPs) with severe (<2 IU/dL endogenous FIX level) hemophilia B and at least 150 prior documented exposure days to other FIX products.
- •Have no prior history of or currently detectable inhibitor defined as > 0.6 Bethesda units by the local lab. A family history of inhibitors will not exclude the patient.
- •No prior history of an allergic reaction or anaphylaxis associated with any FIX or IVIG administration.
- •No concurrent autoimmune disease.
- •At least 7 days since their last dose of FIX (wash-out period).
- •Certain laboratory testing criteria and other protocol-defined criteria may apply.
- •HIV negative or if HIV positive with a CD4 count ≥ 200 cells/mm
- •HIV patients are allowed to receive protease inhibitors per the discretion of the Investigator.
排除标准
- •Presence of a major bleeding episode on Day 1 of study.
- •Any coagulation disorder in addition to hemophilia B.
- •A patient currently on a dose and regimen of FIX that would preclude participation in the study due to possible increased risk of bleeding because of the requirement to withhold treatment during the study period.
- •A positive d-dimer at screening.
- •Documented history of liver cirrhosis.
- •Positive for HBsAg and/or positive for hepatitis C antibody, and/or HIV positive with an ALT or AST greater than 5 times upper limit of normal.
- •Certain prior illnesses and other protocol-defined criteria.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
rFIXFc
Experimental
Six intravenous (IV) dose levels, 1, 5, 12.5, 25, 50, and 100 IU/kg
干预措施: rFIXFc (Drug)
结局指标
主要结局
Number of Participants experiencing Adverse Events
时间窗: Up to 45 days
次要结局
- Half-life (t½)(Up to 45 days)
- Clearance (CL)(Up to 45 days)
- Factor IX protein (FIX) activity(Up to 45 days)
- Mean residence time (MRT)(Up to 45 days)
- Incremental recovery (K)(Up to 45 days)
- Volume of distribution (Vd)(Up to 45 days)
- Time to reach maximum concentration (Tmax)(Up to 45 days)
- Maximum concentration (Cmax)(Up to 45 days)
- Area under the curve (AUC)(Up to 45 days)
- Recombinant (FIXFc) concentration over time curves(up to 45 days)
研究者
研究点 (6)
Loading locations...
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