CTRI/2011/04/001676已完成3 期
Phase I/II/III Pharmacokinetic and Outcome Study of Recombinant Factor IX Product, IB1001, in Subjects with Hemophilia B. - RACE
Aptevo Bio Therapeutics LLC0 个研究点目标入组 80 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
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
入选标准
- •Criteria for Inclusion
- •1. Patient must be willing to give written Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent, make the required study visits, and follow instructions while enrolled in the study.
- •2. Severe (factor IX activity less than or equal to 2 U/dL) hemophilia B subjects on-demand therapy with a minimum of 3 bleeding episodes over the preceding 6 months or 6 bleeding episodes over the preceding 12 months; subjects on prophylaxis with a bleeding pattern as above demonstrated prior to starting prophylaxis.
- •3. Immunocompetent (CD4 count greater than 400/mm3) and not receiving immune modulating or chemotherapeutic agents.
- •4. Previously treated patients with a minimum of 150 exposure days to a factor IX preparation.
- •5. Platelet count at least 150,000/mm3.
- •6. Liver function: alanine transaminase [ALT] and aspartate transaminase [AST] less than or equal to 2 times the upper limit of the normal range.
- •7. Total bilirubin less than or equal to 1.5 times the upper limit of the normal range.
- •8. Renal function: serum creatinine less than or equal to 1.25 times the upper limit of the normal range.
- •9. Willingness to participate in the trial for up to 12-15 months.
- •10. European Union (EU), Israel, and India: Age of at least 12 years and body weight of greater than or equal to 40 kilograms to participate in any PK Study or the Surgical Sub-study; age of at least 12 years for the prophylaxis and on-demand components of the Treatment Phase and Continuation Study.
- •Subjects in France less than 18 years of age will not be included in any PK study.
- •United States (US): Age of at least 12 years and body weight of greater than or equal to 40 kilograms to participate in any PK Study or the Surgical Sub-study; age of at least 5 years for the prophylaxis and on-demand components of the Treatment Phase and Continuation Study.
- •11. Hemoglobin greater than or equal to 7 g/dL at the time of the blood draw.
排除标准
- •Criteria for Exclusion
- •1.History of factor IX inhibitor ¡Ý0.6 Bethesda units (BU)
- •2.Existence of another coagulation disorder
- •3.Evidence of thrombotic disease,fibrinolysis,or
- •disseminated intravascular coagulation (DIC)
- •4.Use of an investigational drug within 30 days prior to study entry
- •5.On medications that could impact hemostasis, such as aspirin
- •6.Hypersensitivity to the active substance or to any of the excipients in the investigational products
- •7.Known allergic reaction to hamster proteins
- •8.History of poor compliance, a serious medical or social condition, or any other circumstance that, in the opinion of the investigator, would interfere with participation or compliance with the study protocol
- •9.History of adverse reaction to either plasma-derived factor IX or recombinant factor IX that interfered with the subject¡¯s ability to treat bleeding episodes with a factor IX product
研究者
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