NCT00606060已完成3 期
Safety and Efficacy of Continuous Infusion of Recombinant Factor VIII - Sucrose-formulated (BAY 14 2222) Concentrate in Patients With Hemophilia A Undergoing Major Elective Surgery.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 15
- 主要终点
- efficacy of continuous infusion of recombinant Factor VIII - sucrose-formulated (rFVIII-FS) in the treatment of patients with hemophilia A
研究概览
简要总结
Phase III study, to evaluate the efficacy and safety of continuous infusion of rFVIII-FS in the treatment of patients with hemophilia A undergoing major elective surgery by achieving the required therapeutic concentrations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Severe hemophilia A (FVIII:C </=1%)
- •No history of FVIII inhibitor formation and no current evidence of inhibitor antibody (Bethesda Assay < 0.6 BU)
- •Elective major surgery requiring at least 6 days of rFVIII-FS therapy
- •Subjects should have been previously treated with FVIII concentrates for at least 150 exposure days. Previous treatment could have been with any type of rFVIII or with plasma-derived FVIII concentrate or cryoprecipitate
排除标准
- •Abnormal renal function (serum creatinine >1.3 mg/dL)
- •Any treatments, which may change the clearance of FVIII (dialysis, plasma exchange)
- •Anemia (hemoglobin <11 g/dL)
- •Known AIDS (HIV seropositive patients may be enrolled)
- •Active liver disease (transaminases > 5 times the upper limit of normal)
- •History of severe reaction to FVIII concentrates
- •Interferon treatment within the last 3 months
- •Thrombocytopenia (< 100,000 platelets/mm3) or other known hematological/bleeding problems other than hemophilia A
- •Intake of other investigational drugs within 1 month prior to study entry
- •Need for pre-medication for FVIII infusions (e.g. antihistamines)
- •Diastolic blood pressure >100 mm/Hg, which could not be controlled with antihypertensive medications
研究组 & 干预措施
Arm 1
Experimental
干预措施: Kogenate (BAY14-2222) (Drug)
结局指标
主要结局
efficacy of continuous infusion of recombinant Factor VIII - sucrose-formulated (rFVIII-FS) in the treatment of patients with hemophilia A
时间窗: 28 days
次要结局
- Evaluate the safety of rFVIII-FS.(28 days)
研究者
相似试验
已完成
3 期
A Phase 3 Study of MR13A11APatients who require at least 6 hours or more mechanical ventilation under intensive care and require analgesics.JPRN-jRCT2080224954Maruishi Pharmaceutical Co., Ltd.196
已完成
3 期
A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia BHemophilia BNCT02053792CSL Behring97
已完成
3 期
A Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency AnemiaIron Deficiency AnemiaNCT01114204AMAG Pharmaceuticals, Inc.605
撤回
3 期
A Phase 3 Study to Evaluate the Efficacy and Safety of Resiniferatoxin for Pain Due to Osteoarthritis of the KneeKnee Pain ChronicOsteoarthritis, KneeNCT04044742Sorrento Therapeutics, Inc.
进行中（未招募）
3 期
Efficacy, Immunogenicity and Safety Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)Condylomata AcuminataCervical CancerCervical Intraepithelial NeoplasiaNCT04537156Xiamen University9,327