NL-OMON38008招募中3 期
A Phase 3 clinical study to determine the pharmacokinetics, safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding episodes in subjects diagnosed with von Willebrand disease - Baxter 071001
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Baxter
- 入组人数
- 4
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 99（—）
入选标准
- •The subject has been diagnosed with:
- •Type 1 (VWF:RCo < 20 IU/dL) or,
- •Type 2A (VWF:RCo< 20 IU/dL), Type 2B (as diagnosed by genotype), Type 2N
- •(FVIII:C<10% and historically documented genetics), Type 2M or,
- •Type 3 (VWF:Ag <= 3 IU/dL) or,
- •Severe VWD with a history of requiring substitution therapy with von Willebrand factor
- •concentrate to control bleeding
- •The subject, who participates for the treatment for bleeding episodes, has had a minimum of 1 documented bleeds (medical history) requiring VWF coagulation factor replacement therapy during the previous 12 months prior to enrollment.
- •The subject has a Karnofsky score >=60.
- •The subject is at least 18 and not older than 65 years of age at enrollment.
排除标准
- •The subject has been diagnosed with pseudo VWD or another hereditary or acquired coagulation
- •disorder other than VWD (eg qualitative and quantitative platelet disorders or elevated PT/
- •international normalized ratio [INR] >1.4).
- •The subject has a documented history of a VWF:RCo half-life of <6 hours.
- •The subject has a history or presence of a VWF inhibitor at screening.
- •The subject has a history or presence of a factor VIII (FVIII) inhibitor with a titer >=0.4 BU (by Nijmegen assay) or >=0.6 BU (by Bethesda assay).
- •The subject has a known hypersensitivity to any of the components of the study drugs, such as to
- •mouse or hamster proteins.
- •The subject has a medical history of immunological disorders, excluding seasonal allergic
- •rhinitis/conjunctivitis, mild asthma, food allergies or animal allergies.
- •The subject has a medical history of a thromboembolic event.
- •The subject is HIV positive with an absolute CD4 count <200/mm3.
- •The subject has been diagnosed with cardiovascular disease (New York Heart Association [NYHA] classes 1-4).
- •The subject has an acute illness (eg, influenza, flu-like syndrome, allergic rhinitis/conjunctivitis, non-seasonal asthma) at screening.
- •The subject has been diagnosed with significant liver disease as evidenced by any of the following: serum alanine aminotransferase (ALT) 5 times the upper limit of normal; hypoalbuminemia; portal vein hypertension (eg, presence of otherwise unexplained splenomegaly, history of esophageal varices).
- •The subject has been diagnosed with renal disease, with a serum creatinine level >=2 mg/dL.
- •In the judgment of the investigator, the subject has another clinically significant concomitant disease (eg, uncontrolled hypertension) that may pose additional risks for the subject.
- •The subject has been treated with an immunomodulatory drug, excluding topical treatment (eg, ointments, nasal sprays), within 30 days prior to signing the informed consent.
研究者
相似试验
Unknown
3 期
A clinical trial to determine the distribution through the patientâ??s body, safety and effectiveness of rVWF and rFVIII in treatment of bleeding episodes in patientâ??s diagnosed with the Von Willebrand Disease.CTRI/2012/01/002390Baxter Healthcare Corporation45
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Clinical study to explore the pharmacokinetics, safety and efficacy of recombinant VWF (in combination with recombinant FVIII and recombinant VWF alone) in the treatment of bleeding episodes in patients with von Willebrand Disease.EUCTR2010-024108-84-ITBAXTER INNOVATIONS GMBH40
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Clinical study to explore the influence of the human body on the study drug, on the safety and the efficacy of recombinant VWF (in combination with recombinant FVIII and recombinant VWF alone) in the treatment of bleeding episodes in patients with von Willebrand Disease.EUCTR2010-024108-84-ATBaxter Innovations GmbH49
进行中（未招募）
不适用
Clinical study to explore the influence of the human body on the study drug, on the safety and efficacy of recombinant VWF (in combination with recombinant FVIII and recombinant VWF alone) in the treatment of bleeding episodes in patients with von Willebrand Disease.EUCTR2010-024108-84-DEBaxter Innovations GmbH49
进行中（未招募）
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Clinical study to explore the influence of the human body on the studydrug, on the safety and the efficacy of recombinant VWF (in combinationwith recombinant FVIII and recombinant VWF alone) in the treatment ofbleeding episodes in patients with von Willebrand Disease.EUCTR2010-024108-84-SEBaxter Innovations GmbH49