The purpose of this study is to find out if denecimig is safe and effective for treating people who have acquired haemophilia A. Participants will be in this study for up to around 1 year and 5 months (73 week).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Participants will receive subcutaneous (s.c.) injections of denecimig.
Number of treated bleeds
Measured as count of treated bleeds.
Time frame: From treatment initiation (week 0) until end of main part (week 12)
Number of treated bleeds
Measured as count of treated bleeds.
Time frame: From initiation of extension part (week 13) up until end of treatment (week 52)
Number of clinically relevant new bleeds
Measured as count of new bleeds.
Time frame: From treatment initiation (week 0) up until end of treatment (week 52)
Days of treatment with bypassing agent (BPAs) or coagulation factor VIII (FVIII) products for management of bleeding episodes
Measured as count of bleeds.
Time frame: From treatment initiation (week 0) up until end of treatment (week 52)
Occurrence of infections
Measured as count of infections.
Time frame: From treatment initiation (week 0) up until end of study (week 73)
Occurrence of antidrug antibodies
Measured as count of antidrug antibodies.
Time frame: From treatment initiation (week 0) up until end of study (week 73)
Denecimig plasma concentration
Measured as microgram per milliliter (μg/mL).
Time frame: From treatment initiation (week 0) up until end of treatment (week 52)
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