Denecimig
DrugParticipants will receive subcutaneous (s.c.) injections of denecimig.
NCT Number: NCT07830732
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).
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 3
Instituto de Hematologia DR.Ruben Davoli, Rosario, Santa Fe Province, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive subcutaneous (s.c.) injections of denecimig.
Time frame: From treatment initiation (week 0) until end of main part (week 12)
Measured as count of treated bleeds.
Time frame: From initiation of extension part (week 13) up until end of treatment (week 52)
Measured as count of treated bleeds.
Time frame: From treatment initiation (week 0) up until end of treatment (week 52)
Measured as count of new bleeds.
Time frame: From treatment initiation (week 0) up until end of treatment (week 52)
Measured as count of bleeds.
Time frame: From treatment initiation (week 0) up until end of study (week 73)
Measured as count of infections.
Time frame: From treatment initiation (week 0) up until end of study (week 73)
Measured as count of antidrug antibodies.
Time frame: From treatment initiation (week 0) up until end of treatment (week 52)
Measured as microgram per milliliter (μg/mL).
Contact information is provided by the study sponsor or research team.
Novo Nordisk A/S
Industry
A Multinational, Open-label Study to Investigate Efficacy and Safety of Denecimig (Mim8) in Adults With Acquired Haemophilia A
Acronym: FRONTIERAHA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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