EUCTR2013-001359-11-DE进行中（未招募）1 期
A Phase 3, Multi-Center, Open Label Study of Efficacy and Safety of PEGylated rFVIII (BAX 855) in Previously Treated Patients With Severe Hemophilia A Undergoing Surgical or Other Invasive Procedures - Ph 3 Efficacy and Safety Study of BAX 855 in Hemophilia A Patients Undergoing Surgical Procedures
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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 requires an elective major surgical, dental or other invasive procedure (e.g. biopsy, endoscopy).
- •2. Subject and/or legal representative has/have provided signed informed consent.
- •3. Subject is 2 to 75 years of age at the time of enrollment.
- •4. Subject is male with severe hemophilia A (FVIII level <1%) as confirmed by the central lab at screening.
- •5. Subject was previously treated with FVIII concentrates with =150 documented exposure days (EDs).
- •6. Subject is currently receiving prophylaxis or on-demand therapy with FVIII concentrate.
- •7. Subject has a Karnofsky performance score of =60 at screening.
- •8. Subject is human immunodeficiency virus negative (HIV-); or HIV+ with stable disease and CD4+ count =200 cells/mm3, as confirmed by central laboratory at screening.
- •9. Subject is Hepatitis C virus negative (HCV-) by antibody or PCR testing, as confirmed by central laboratory at screening; or HCV+ with chronic stable hepatitis as assessed by the investigator. If positive, antibody titer will be confirmed by PCR.
- •10. Subject is willing and able to comply with the requirements of the study protocol.
- •11. For subjects transitioning from parent Bax855 studies, the subjects contunies to meet the entry criteria.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Subject has detectable FVIII inhibitory antibodies (=0.4 BU using the Nijmegen modification of the Bethesda assay) at screening as determined by the central laboratory or at any timepoint prior to screening (=0.4 BU using the Nijmegen modification of the Bethesda assay or =0.6 BU using the Bethesda assay).
- •2. History of ongoing or recent thrombotic disease, fibrinolysis or disseminated intravascular coagulation (DIC).
- •3. Subject has a platelet count <100 x 109/L, as confirmed by central laboratory at screening.
- •4. Subject has severe renal impairment (serum creatinine > 2.0 mg/dL), as confirmed by central laboratory at screening.
- •5. Subject has severe chronic hepatic dysfunction (eg =5 X upper limit of normal alanine aminotransferase (ALT), as confirmed by central laboratory at screening, or a documented INR > 1.5).
- •6. Subject has a known hypersensitivity towards mouse or hamster proteins, polysorbate 80 or to PEG.
- •7. Subject is currently using or has recently (< 30 days) used pegylated drugs (other than BAX855) prior to study participation or is scheduled to use such drugs during trial participation.
- •8. Subject is currently participating in another clinical drug (other than BAX855) or device study or use of another investigational product or device within 30 days prior to study entry.
- •9. Subject has a diagnosis of an inherited or acquired hemostatic defect other than hemophilia A.
- •10. Subject is currently receiving, or scheduled to receive during the course of the study, an immunomodulating drug (e.g., systemic corticosteroid agent at a dose equivalent to hydrocortisone greater than 10 mg/day, or alpha interferon) other than anti-retroviral chemotherapy.
- •11. Subject has a clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject safety or compliance.
- •12. The subject has an incremental recovery <1.5 IU/dL:IU/kg as determined in the parent study, if
- •applicable.
- •13. Subjects undergoing minor or major emergency surgery.
研究者
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