A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Hematology, Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/19/2018 |
| Start Date: | August 10, 2017 |
| End Date: | January 31, 2020 |
A Multi-Centre, Randomised, Open-Label, Controlled Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors
This trial is conducted in Africa, Asia, Europe and North America. The aim of the trial is to
assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once
daily in preventing bleeding episodes in haemophilia A and B patients with inhibitors.
assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once
daily in preventing bleeding episodes in haemophilia A and B patients with inhibitors.
Inclusion Criteria: - Informed consent obtained before any trial related activities. Trial
related activities are any procedures that are carried out as part of the trial, including
activities to determine the suitability for the trial - Male haemophilia A or B patients
with inhibitors aged 18 years or older at the time of signing informed consent - Patients
currently in need of treatment with bypassing agents Exclusion Criteria: - Known or
suspected hypersensitivity to trial product(s) or related products - Known inherited or
acquired bleeding disorder other than haemophilia - Ongoing or planned immune tolerance
induction therapy or prophylaxis with FVIII or FIX
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