A prospective, multi-national, non-interventional study inhaemophilia A and B patients with or without inhibitorstreated according to routine clinical treatment practice

ovo Nordisk India Private Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1. Informed consent obtained before any study-related activities. Study-related activities are any
•procedures that are carried out as part of the study, including activities to determine eligibility
•for the study.
•2. Male, age Ã¢â?°Â¥ 12 years at the time of signing informed consent.
•3. Severe (FVIII activity < 1%) congenital haemophilia A or severe (FIX activity < 1%) congenital
•haemophilia B or congenital haemophilia A or B with inhibitors, based on medical records at
•the full discretion of the treating physician.
•4. Patients with CHwI treated on-demand: Ã¢â?°Â¥ 6 treated (with bypassing agent) bleeding episodes
•within 24 weeks before screening (visit 1) and patients with severe congenital HA/HB treated
•on-demand: Ã¢â?°Â¥ 5 treated (with factor product) bleeding episodes within 24 weeks before
•screening (visit 1).
•5. Patients with congenital haemophilia with inhibitors treated with FEIBAÃ?Â® prophylaxis: Ã¢â?°Â¥ 2
•treated bleeding episodes within 24 weeks before screening (visit 1).

•1. Known or suspected hypersensitivity to monoclonal antibodies.
•2. Previous participation in this study. Participation is defined as signed informed consent.
•3. Any disorder, except for conditions associated with congenital haemophilia, which in the
•physicianÃ¢â?¬•s opinion might jeopardise patientÃ¢â?¬•s safety or compliance with the protocol.
•4. Previous treatment with concizumab. Previous treatment is defined as two or more doses
•administered.
•5. Planned FVIII/FIX Immune Tolerance Induction (ITI) regimens during the study.
•6. Current or planned treatment with emicizumab.
•7. Any known congenital or acquired coagulation disorder other than congenital haemophilia.

发起方

ovo Nordisk India Private Ltd