An Evaluation of the Safety and Efficacy of On-Demand Treatment with Xyntha (B-Domain Deleted Recombinant Factor VIII, Albumin Free) in Chinese Subjects with Hemophilia A

Wyeth Pharmaceutical Co., Ltd0 个研究点目标入组 53 人开始时间: 2015年4月3日最近更新: 2015年4月13日

适应症

试验速览

暂无简介。

•1.Subjects equal or more than 6 years of age with mild, moderate or severe hemophilia A (FVIII activity: more than 5 percentage (%), 1-5%, or less than 1%, respectively).
•2.Subjects with previous exposure to FVIII replacement therapy.
•3.If human immunodeficiency virus (HIV) positive, documented cluster of differentiation (CD4) count more than 200 per microliter (mcL) within 6 months of study entry.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 53
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 37
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Diagnosed with any bleeding disorder in addition to hemophilia A.
•2.Current FVIII inhibitor or history of FVIII inhibitor (defined as positive result of the reporting laboratory).
•3.Subject has no history of exposure to FVIII products (previously untreated patient [PUP]).
•4.Subject is currently utilizing primary FVIII prophylaxis.
•5.Subjects anticipating elective surgery that may be planned to occur in the 6 months following study entry.
•6.Treated with immunomodulatory therapy within 30 days prior to study entry or planned use for the duration of their study participation.
•7.Participated in another investigational drug or device study within 30 days prior to study entry or planned participation for the duration of their study participation.
•8.Subjects with a known hypersensitivity to hamster protein.
•9.Significant hepatic or renal impairment (alanine aminotransferase [ALT] and aspartate aminotransferase [AST] >5*upper limit of normal [ULN], bilirubin greater than (>) 2 microgram per deciliter (mg/dL) or serum creatinine >1.25 *ULN).
•10.Prothrombin Time >1.5 * ULN.
•11.Platelet count less than (<) 80,000/mcL.
•12.Pregnant or breastfeeding women.
•13.Unwilling or unable to follow the terms of the protocol.
•14.Any condition which may compromise the subject's ability to comply with and/or perform study-related activities or that poses a clinical contraindication to study participation, in the opinion of the Investigator or Sponsor.

发起方

Wyeth Pharmaceutical Co., Ltd