A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia A
ConditionHaemophilia A
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovo Nordisk A/S
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
Male or female participants (sex assigned at birth, inclusive of all gender identities) newly diagnosed with acquired haemophilia A (AHA) prior to signing the informed consent form, with AHA diagnosis (FVIII activity lesser than (<) 50 percentage (%) and FVIII inhibitors greater than (>) 0.6 Bethesda units [BU]) confirmed at screening.
Treatment-requiring bleed(s) due to AHA from diagnosis and until screening.
The participant is capable of following study procedures and able to seek medical attention when needed.
Disqualifiers
Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate and highly effective contraceptive method.
Previous or current thromboembolic disease or eventsa (with the exception of previous catheter associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or risk of thromboembolic disease.
Life expectancy <3 months at the time of screening, as evaluated by the investigator.
Therapy with immunosuppressive or immune modulating drugs for treatment of AHA (other than less than or equal to (≤) 2 days of prednisolone (or equivalent) for AHA at a dose ≤100 mg per day) prior to screening.
Trial design
Design model
Single group
Treatments tested in this trial
Denecimig
DrugParticipants will receive subcutaneous (s.c.) injections of denecimig.
Treatment groups
84 Participants
are divided into 1 treatment groupGroup A: DenecimigExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of treated bleeds
Measured as count of treated bleeds.
Time frame
From treatment initiation (week 0) until end of main part (week 12)Secondary outcomes
1
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)2
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)3
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)4
Occurrence of infections
Measured as count of infections.
Time frame
From treatment initiation (week 0) up until end of study (week 73)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: