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This study is an international, multicenter, open-label, single arm, prospective clinical trial and will evaluate the efficacy of prophylactic emicizumab administered on a scheduled basis to prevent bleeds in patients with acquired hemophilia A (AHA).
Enrollment
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Inclusion criteria
Exclusion criteria
Congenital hemophilia A
Partial or complete remission of AHA (defined as FVIII activity ≥ 50 % and no bleeding and no hemostatic therapy) at the time of screening
Treatment with aPCC within the last 48 h before first study treatment or planned treatment with aPCC during the course of the study
Treatment of AHA within the days before study enrollment with more than 100 mg prednisolone (or equivalent) per day or prednisolone for more than 2 days or with other immunosuppressive drugs (e.g. rituximab, cyclophosphamide). IST for other concomitant disorders (e.g. autoimmune disorders) is not an exclusion criterion and can be continued at the investigator's discrétion
Therapy (current or planned during the emicizumab treatment period) with immunosuppressive or immune modulating drugs that were not already given on a regular basis before first diagnosis of AHA
Positive lupus anticoagulant at the time of screening
Severe uncontrolled infection at the time of screening
Signs of active disseminated intravascular coagulation at the time of screening
Current treatment for thromboembolic disease or signs of current thromboembolic disease at time of screening
Patients who are at high risk for TMA (e.g., have a previous medical or family history of TMA), in the investigator's judgment
Known severe congenital or acquired thrombophilia
Life expectancy <3 months at the time of screening
Other conditions that substantially increase risk of bleeding or thrombosis by the discretion of the investigator
Contraindications according to the local SmPC of emicizumab (see 16.1 Appendix I)
Current treatment with emicizumab at time of screening
History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection by the discretion of the investigator
Concurrent disease, treatment, or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose additional risk, or would, in the opinion of the local investigator, preclude the patient's safe participation in and completion of the study
Addiction or other diseases that preclude the patient from appropriately assessing the nature and scope as well as possible consequences of the clinical study by the discretion of the investigator
Pregnant or breast-feeding women
Women of childbearing potential unless women who meet the following criteria:
Men of sexual activity with women of childbearing potential who are not willing to use an effective barrier method of contraception during and up to 3 months after the end of therapy
Subject is in custody by order of an authority or a court of law
Receipt of an investigational drug concurrently or within 5 half-lives before administration of the study drug
Primary purpose
Allocation
Interventional model
Masking
47 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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