EUCTR2011-000520-15-PL进行中（未招募）不适用
A MULTICENTER, OPEN LABEL STUDY TO COMPARE ON DEMAND TREATMENT TO A PROPHYLAXIS REGIMEN OF NONACOG ALFA (BENEFIX) IN SUBJECTS WITH MODERATELY SEVERE TO SEVERE HEMOPHILIA B (FIX:C =2%) - Benefix 1010
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
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
- •Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study.
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- •1. Documented history of moderately severe to severe hemophilia B (FIX activity =2%).
- •2. Male subjects, aged 12 years to 65 years.
- •3. Subjects with at least 100 exposure days (EDs) to factor IX products.
- •4. Subjects with a minimum of 12 bleeding episodes, 6 of which must be joint bleeds, in the 12 month period before the Screening visit.
- •5. Evidence of a personally signed and dated informed consent/assent document indicating that the subject and if applicable, a legally acceptable representative, has been informed of all pertinent aspects of the study.
- •6. Subjects (and if applicable, their legal guardians), who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •Subjects presenting with any of the following will not be included in the study:
- •1. Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
- •2. Subjects who have received FIX as a primary or secondary prophylaxis regimen within the last 12 months prior to the Screening visit.
- •3. For documented HIV+ subjects, CD4 count <200 µL.
- •4. Subjects with hepatic or renal impairment (ALT and AST =5x Upper limit of normal (ULN), bilirubin >2 mg/dL, albumin 1.25 x ULN).
- •5. Prothrombin time (PT) >1.5 x ULN or international normalized ratio (INR) >1.5.
- •6. Platelet count <100,000/µL.
- •7. Subjects who have had major surgery or an orthopedic surgical procedure within the past 3 months prior to Screening visit.
- •8. Subjects for which major surgery or orthopedic surgery is planned within the duration of study participation.
- •9. Subjects with a past history of, or current FIX inhibitor, defined as >ULN of the reporting laboratory.
- •10. Subjects with a known hypersensitivity to any FIX product or hamster protein.
- •11. Subjects who received any investigational drug or device within 30 days of Screening visit.
- •12. Subjects with bleeding disorders other than hemophilia B.
- •13. Subjects with a documented concurrent inflammatory disease that in the investigator’s judgment could confound the study results (eg, systemic lupus, rheumatoid arthritis or inflammatory bowel disease).
- •14. Subjects with poor venous access.
- •15. Participation in other studies (except observational and epidemiological studies) within 30 days before the current study begins.
- •16. Participation in any other studies during study participation.
- •17. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
研究者
相似试验
进行中（未招募）
1 期
Study to compare on-demand treatment to a prophylaxis regimen of BeneFIX in Hemophilia B subjects with a Factor IX activity:=2%Hemophilia BMedDRA version: 14.1Level: LLTClassification code 10060614Term: Hemophilia B (Factor IX)System Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2011-000520-15-GRPfizer Inc., 235 East 42nd Street, New York, NY 1001725
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-BGPfizer Inc., 235 East 42nd Street, New York, NY 1001724
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-Outside-EU/EEAPfizer Inc., 235 East 42nd Street, New York, NY 1001724
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