An 18-month low-interventional prospective, multicentre study to assess joint outcomes in patients with haemophilia A or B on prophylaxis with efmoroctocog alfa or eftrenonacog alfa - Sobi.HAEM89-007

Swedish Orphan Biovitrum AB (publ)0 个研究点目标入组 250 人开始时间: 2023年2月17日最近更新: 2024年8月21日

适应症

试验速览

ow Intervention Clinical Trial Report Summary

•Age = 6 years, Diagnosis of haemophilia A or B, Having at least 6 months documented pre-study treatment data regarding treatment prescriptions and bleeding episodes prior to the baseline visit, Previous treatment for haemophilia A or B with any marketed recombinant and/or plasma-derived FVIII or FIX concentrate for at least 6 months, Start of prophylactic treatment with rFVIIIFc or rFIXFc prior to study enrolment or latest at the baseline visit, in accordance with local regulations, Signed and dated informed consent provided by the patient, or the patient’s legally authorized representative for patients under the legal age. Assent should be obtained from paediatric patients in accordance with local regulations, To be eligible for the florio HAEMO sub-study a patient should have used florio HAEMO (a CE marked medical device used in routine clinical practice) for at least 3 months and must agree to have data collected from the florio HAEMO app by providing a separate informed consent or assent

•Any medical condition which in the opinion of the investigator makes the patient unsuitable for inclusion, Prophylactic treatment with non-factor therapy during the 6 months prior to enrolment, Presence of factor VIII or FIX inhibitory antibodies (inhibitors) (=0.60 Bethesda Units [BU]/mL) at the latest available inhibitor test, Enrolment in a concurrent clinical interventional study, or intake of an Investigational medicinal product, within 3 months prior to inclusion in this study, Foreseeable inability to cooperate with given instructions or study procedures

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