Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery

Launched by OCTAPHARMA · Jul 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called Nuwiq, which is a type of factor VIII, in helping prevent bleeding during major surgeries for women and girls with Hemophilia A. Hemophilia A is a condition where the blood doesn't clot properly, and this trial aims to understand how well Nuwiq works for those who need FVIII treatment before and after their surgery.

To participate in this trial, you must be a woman or girl aged 12 years or older with Hemophilia A, specifically with a certain level of factor VIII in your blood. You should also be scheduled for a major elective surgery that requires treatment with factor VIII. However, if you have other bleeding disorders, certain liver or kidney issues, or if you are currently pregnant, you may not be eligible. Participants in this trial will receive the Nuwiq treatment and will be monitored to see how effective it is in preventing bleeding during their surgery. If you or a family member are considering this trial, it’s important to discuss it with your healthcare provider to understand all the details and make an informed decision.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Women/girls with haemophilia A (FVIII:C ≥1-\<40%) according to medical history
• • 2. At least 12 years of age
• • 3. Scheduled to undergo major elective surgery requiring FVIII treatment
• • 4. Freely given written informed consent of the patient, or parent/legal representative where applicable, obtained in accordance with local regulations
• Exclusion Criteria:
• • 1. Coagulation disorder other than haemophilia A
• • 2. Present or past FVIII inhibitor (≥0.6 Bethesda units \[BU\]/mL)
• • 3. 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)
• • 4. Known hypersensitivity to Nuwiq's active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188)
• • 5. Pregnancy
• • 6. Already had surgery in this study
• • 7. Current participation in another interventional clinical trial
• • 8. Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit