Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study
ConditionSevere Hemophilia A
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age12+
SponsorOctapharma
About this trial
Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis
Eligibility criteria
Qualifiers
Severe haemophilia A (FVIII activity [FVIII:C] <1%) according to medical history
Male patients at least 12 years of age
Previous treatment with any FVIII product(s) for at least 150 exposure days
On regular prophylaxis with emicizumab for at least 1 month prior to a scheduled major elective surgery requiring FVIII treatment
Disqualifiers
Coagulation disorder other than haemophilia A
Present or past FVIII inhibitor (≥0.6 Bethesda units [BU]/mL) according to medical history
Severe liver or kidney disease (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] levels >5 times the upper limit of normal; or creatinine >120 μmol/L)
Known hypersensitivity to Nuwiq's active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188)
Trial design
Treatments tested in this trial
- Nuwiq
Treatment groups
28 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov