EUCTR2005-005246-40-IT进行中（未招募）不适用
A Multicenter, Open-Label Study to Compare On-Demand Treatment With 2 Prophylaxis Regimens of Recombinant Coagulation Factor IX BeneFIX Reformulated Drug Product rFIX-R in Subjects With Severe Hemophilia B - Profhylaxis Clinical Study
Wyeth Pharmaceuticals Inc. Global Medical Affairs0 个研究点目标入组 35 人开始时间: 2007年3月9日最近更新:
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
- 入组人数
- 35
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
- Male
入选标准
- •1.Documented history of moderately severe or severe hemophilia B FIX C 2 2. Male subjects, aged 612 years to 65 years. 3.Subjects with a minimum of 12 bleeding episodes, 6 of which must be joint bleeds, in the 12 months before screening.
- •Are the trial subjects under 18? yes
- •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.Subjects currently utilizing FIX primary prophylaxis. 2.For documented HIV subjects, CD4 count 200. 3.Subjects with hepatic or renal impairment ALT and AST 5x ULN, bilirubin 2 mg/dL, serum albumin LLN, serum creatinine 1.25 x ULN . 4.Prothrombin time 1.5 x ULN. 5.Platelet count 150,000/ L. 6.Subjects who have had major surgery or an orthopedic surgical procedure within the past 3 months. 7.Subjects for which major surgery or orthopedic surgery is planned within the duration of participation in this study. 8.Subjects with a past history of, or current FIX inhibitor, defined as ULN of the reporting laboratory. 9.Subjects with a known hypersensitivity to any FIX product or hamster protein. 10.Exposure to any investigational drug, except for BeneFIX, or device within 30 days of providing consent/assent as appropriate for this study. 11.Subjects with bleeding disorders other than hemophilia B. 12.Documented concurrent inflammatory disease that in the investigator s judgment could confound the study results eg. systemic lupus, rheumatoid arthritis or inflammatory bowel disease . 13.Subjects unwilling to adhere to the terms of this protocol. 14.Subjects with poor venous access, or who are otherwise inappropriate candidates for this trial in the judgment of the investigator.
研究者
相似试验
进行中（未招募）
不适用
Study to compare on-demand treatment with 2 prophylaxis regimens of BeneFIX in severe Hemophilia B subjectsEUCTR2005-005246-40-Outside-EU/EEAWyeth Pharmaceuticals Inc.40
进行中（未招募）
不适用
A Multicenter, Open-Label Study to Compare On-Demand Treatment With 2 Prophylaxis Regimens of Recombinant Coagulation Factor IX (BeneFIX) Reformulated Drug Product (rFIX-R) in subjects with Severe Hemophilia B.Male subjects, aged 6 years to 65 years, with a documented history of moderately severe or severe Hemophilia B (FIX:C=2%) and with a minimum of 12 bleeding episodes, of which 6 must be joint bleeds, in the 12 months before screening.MedDRA version: 8.1Level: LLTClassification code 10060614Term: Hemophilia B (Factor IX)EUCTR2005-005246-40-BEWyeth Pharmaceuticals Inc. - Global Medical Affairs40
进行中（未招募）
不适用
A Multicenter, Open-Label Study to Compare On-Demand Treatment With 2 Prophylaxis Regimens of Recombinant Coagulation Factor IX (BeneFIX) Reformulated Drug Product (rFIX-R) in subjects with Severe Hemophilia B.Male subjects, aged 6 years to 65 years, with a documented history of moderately severe or severe Hemophilia B (FIX:C=2%) and with a minimum of 12 bleeding episodes, of which 6 must be joint bleeds, in the 12 months before screening.MedDRA version: 8.1Level: LLTClassification code 10060614Term: Hemophilia B (Factor IX)EUCTR2005-005246-40-HUWyeth Pharmaceuticals Inc. - Global Medical Affairs40
进行中（未招募）
不适用
A Multicenter, Open-Label Study to Compare On-Demand Treatment With 2 Prophylaxis Regimens of Recombinant Coagulation Factor IX (BeneFIX) Reformulated Drug Product (rFIX-R) in Subjects with Severe Hemophilia B. - Prophylaxis Clinical StudyMale subjects, aged 6 years to 65 years, with a documented history of moderately severe or severe Hemophilia B (FIX:C<2%) and with a minimum of 12 joint bleeding episodes, of which 6 must be joint bleeds, in the 12 months before screening.MedDRA version: 8.1Level: LLTClassification code 10060614Term: Hemophilia B (Factor IX)EUCTR2005-005246-40-DEWyeth Pharmaceuticals Inc. - Global Medical Affairs35
进行中（未招募）
不适用
Study to compare on-demand treatment to a prophylaxis regimen of BeneFIX in Hemophilia B subjects with a Factor IX activity:=2%Hemophilia BEUCTR2011-000520-15-PLPfizer Inc., 235 East 42nd Street, New York, NY 1001724