Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study

Launched by OCTAPHARMA · Jul 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Nuwiq, which is used to help prevent bleeding in male patients with severe Hemophilia A who are undergoing major surgery. These patients are already receiving another treatment called emicizumab to help manage their condition. The trial aims to see how effective Nuwiq is in preventing bleeding during and after surgery for these individuals.

To participate in the study, patients must be male, at least 12 years old, and have a severe form of Hemophilia A. They should have had prior treatment with factor VIII products and must have been on emicizumab for at least one month before their scheduled surgery. Participants will need to give their consent to join the study, and they will be monitored closely during the trial. It’s important to note that some individuals may not be eligible if they have certain medical conditions or have had prior surgeries in this study. Overall, this trial is an important step in finding better ways to manage bleeding risks in patients with Hemophilia A during surgery.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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
• • Freely given written informed consent of the patient, or parent/legal representative where applicable, obtained in accordance with local regulations
• Exclusion Criteria:
• • 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)
• • Already had surgery in this study
• • Current participation in another interventional clinical trial
• • Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit