Post-marketing investigation (PMI) to assess safety and efficacy of Jivi® (BAY 94-9027) treatment in patients with hemophilia A

Bayer Consumer Care AG0 个研究点目标入组 30 人开始时间: 2020年4月28日最近更新: 2020年9月7日

适应症

试验速览

暂无简介。

•1. Participants must = 18 years of age inclusive, at the time of signing the informed consent
•2. Participants with severe hemophilia A (FVIII: C<1%)
•3. PTPs (=150 ED) on prophylaxis treatment before enrollment
•4. Participants who are immunocompetent. If human immunodeficiency virus (HIV) positive, cluster of differentiation 4 (CD4)+ lymphocyte count >200/mm3
•5. Participants who are willing to complete an eDiary
•Male participants
•6. Capable of giving signed informed consent as described in Section 10.1.3 of the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol
•Are the trial subjects under 18? no
•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 26
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 4

•1. Any other inherited or acquired bleeding disorder in addition to Hemophilia A.
•2. Platelet count < 100,000/mm3
•3. The participant has a planned major surgery.
•4. The participant is currently participating in another investigational drug study, or has participated in a clinical study involving an investigational drug within 30 days of signing informed consent or previous treatment in a clinical phase III study with BAY 94-9027 (now marketed as Jivi®).
•5. Current evidence (by central laboratory) or history of inhibitor to FVIII with a titer = 0.6 Bethesda unit (BU).
•6. Known hypersensitivity to the drug substance, excipients, or mouse or hamster protein.
•7. Creatinine > 2x upper limit of normal
•8. AST or ALT > 5x upper limit of normal (AST: aspartate aminotransferase; ALT: alanine aminotransferase)

发起方