EUCTR2005-005697-71-ES进行中（未招募）不适用
Factor antihemofílico (recombinante), Método Libre de Plasma/Albúmina (rAHF-PFM): Un Estudio Multicéntrico, Aleatorizado, Controlado, Prospectivo y de Fase 4 para Comparar la Eficacia y Seguridad de la Infusión Continua (CI, por sus siglas en inglés) frente a la Infusión de Bolo Intermitente (BI, por sus siglas en Inglés) en Pacientes con Hemofilia A Grave o Moderadamente Grave sometidos a Sustitución Primaria Unilateral Total de Rodilla - Advate Randomized Surgery
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Baxter AG
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. The subject or the subject’s legally authorized representative has provided signed informed consent.
- •2. The subject is within 18 to 65 years of age.
- •3. The subject has severe or moderately severe hemophilia A, defined by a baseline factor VIII level = 2% of normal (based on both the chromogenic and the one-stage aPTT-based assays), as tested at screening. A subset of 15 subjects per group must have baseline factor VIII levels <1% of normal.
- •4. The subject is scheduled to undergo an elective unilateral primary total knee replacement (with cemented or uncemented prosthesis).
- •5. The subject was previously treated with factor VIII concentrate(s) for a minimum of at least 150 exposure days (as estimated by the investigator) prior to study entry.
- •6. Human immunodeficiency virus (HIV) positive subjects must be immunocompetent as determined with a CD4 count = 400 cells/mm³ (CD4 count at screening).
- •7. The subject has a life expectancy of at least 28 days from the day of surgery.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. The subject has a detectable factor VIII inhibitor at screening, with a titer = 0.4 BU (Nijmegen modification of the Bethesda Assay) in the central laboratory.
- •2. The subject has a history of factor VIII inhibitors with a titer ³ 0.4 BU (by Bethesda or Nijmegen assay) at any time prior to screening.
- •3. The subject is scheduled to undergo any other concurrent minor or major surgery during the course of the study. The placement of central venous lines is permitted.
- •4. The subject has an abnormal renal function (serum creatinine > 1.5 mg/dL).
- •5. The subject has active hepatic disease (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] levels > 5 times the upper limit of normal).
- •6. The subject has severe chronic liver disease as evidenced by, but not limited to, any of the following: International Normalized Ratio (INR) > 1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.
- •7. The subject has clinical and/or laboratory evidence of abnormal hemostasis from causes other than hemophilia A (e.g., late-stage chronic liver disease, immune thrombocytopenia purpura).
- •8. The subject is currently receiving, or is scheduled to receive during the course of the study, an immunomodulating drug other than anti-retroviral chemotherapy (e.g., a-interferon, corticosteroid agents at a dose equivalent to hydrocortisone greater than 10 mg/day).
- •9. The subject has a known hypersensitivity to mouse or hamster proteins.
- •10. The subject is participating in another investigational drug study within 30 days prior to screening.
- •11. The subject is identified by the investigator as being unable or unwilling to cooperate with study procedures.
研究者
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?Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method (rAHF?PFM): A Phase 3/4, prospective, controlled, randomized, multi-center Study to compare the efficacy and safety of continous infusion (CI) versus intermittent bolus infusion (BI) in subjects With Severe Or Moderately Severe Hemophilia A undergoing unilateral primary total knee replacement? - Advate Randomized Surgery StudyPatients suffering from severe to moderately severe Haemophilia A (basal level of factor VIII < 2% of normal) undergoing Primary Total Unilateral Substitution of the Knee.MedDRA version: 9.1Level: LLTClassification code 10061992Term: HaemophiliaEUCTR2005-005697-71-ITBaxter Innovations GmbH60
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The main goal of the study is to compare the safety and effectiveness of administering ADVATE using either continuous infusion or single, large dose infusions during and post surgery for patients requiring major orthopedic surgeryEUCTR2005-005697-71-PLBaxalta Innovations GmbH21
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The main goal of the study is to compare the safety and effectiveness of administering ADVATE using either continuous infusion or single, large dose infusions during and post surgery for patients requiring major orthopedic surgerySubjects with Severe or Moderately Severe Hemophilia A (baselinefactor VIII (FVIII) level <= 2% of normal) hemophilia A undergoing major orthopedic surgeryMedDRA version: 17.0Level: LLTClassification code 10060612Term: Hemophilia ASystem Organ Class: 100000004850EUCTR2005-005697-71-BEBaxter Innovations GmbH72