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Nuwiq for Severe Hemophilia A During Surgery

This study is looking at how well Nuwiq, a recombinant factor VIII (a protein needed for blood clotting), works to prevent bleeding during and after major surgery for men with severe hemophilia A. You could be eligible if you are at least 12 years old, have severe hemophilia A (meaning your FVIII activity is less than 1%), and have been on regular emicizumab (a medicine to prevent bleeding) for at least one month. The study will measure how effective Nuwiq is at controlling bleeding during surgery and until your wound heals, for up to about 30 days after surgery. The current status of this study is unclear, and it plans to enroll 28 participants.

Study design
This is a single-arm study, meaning all participants will receive the same treatment. It is open-label, so both you and your doctors will know you are receiving Nuwiq. The study aims to enroll 28 participants.
What's involved
You would receive Nuwiq during and after your major surgery. The study will monitor your bleeding control until your wound heals, which could be up to about 30 days after surgery.
Compensation
Not stated in the trial record.
Follow-up
Your bleeding control will be monitored during surgery and until your wound healing is complete, for about 30 days after the surgical procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05935358

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

Recruiting
PHASE4Ages 12+InterventionalTreatment
Octapharma
~28 participants
Updated 2026-05-12 on ClinicalTrials.gov
What's tested:Nuwiq

At a glance

Recruiting sites
17 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall haemostatic efficacy
Measured over During surgery and until completion of wound healing (e.g. removal of sutures, cessation of drainage, etc.) as defined by the investigator, during the study duration of 30 ± 3 days after the day of surgical procedure

Conditions

Severe Hemophilia A

Explore related trials

Hemophilia A

Where it's being run

18 sites across 12 states
Germany3
Italy3
France2
Spain2
Texas1
Croatia1
Finland1
Tamil Nadu1

Study leadership

  • Shveta Gupta, MD · PRINCIPAL_INVESTIGATOR · Arnold Palmer Hospital for Children

Who to contact

Sigurd Knaub, PhD
[email protected]
+41 554512141
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Overall haemostatic efficacyDuring surgery and until completion of wound healing (e.g. removal of sutures, cessation of drainage, etc.) as defined by the investigator, during the study duration of 30 ± 3 days after the day of surgical procedure

    Overall haemostatic efficacy of treatment measured as binary "success" or "failure". The overall perioperative haemostatic efficacy of Nuwiq will be adjudicated by an Independent Data Monitoring Committee (IDMC) and determined using a composite assessment algorithm that considers the surgeon's assessment of intraoperative haemostatic efficacy and the investigator's assessment of postoperative haemostatic efficacy to classify the overall haemostatic efficacy as success or failure.