Severe Hemophilia A study: Nuwiq
Official title Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study
ClinicalTrials.gov ID: NCT05935358
What this study is testing
What is Nuwiq?
Nuwiq is an investigational injectable medicine being studied to help prevent bleeding during major surgery in people with severe hemophilia A. It is designed to replace the missing clotting factor VIII in the blood to help form clots and stop bleeding.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study looks at how well a specific blood-clotting medicine works to prevent bleeding during major surgery.
- Who it's for
- The study is for people with severe Hemophilia A who are already taking a preventive medicine called emicizumab.
- What's involved
- Participants will receive a blood-clotting medicine called recombinant factor VIII before and during major surgery.
- Time commitment
- The study covers the time around major surgery, including necessary medical visits and tests.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older, men only
You may be able to join if
- 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
You likely can't join if
- 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
- Known hypersensitivity to Nuwiq's active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride...
- Already had surgery in this study
- Current participation in another treatment clinical trial
See the full eligibility 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
- 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 treatment clinical trial
- Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit
The study team makes the final eligibility decision.
Where it is enrolling
- Dallas, Texas, United States
- Zagreb, Croatia
- Helsinki, Finland
- Nantes, France
- Tours, France
- Berlin, Germany
- Duisburg, Germany
- Hamburg, Germany
- Vellore, Tamil Nadu, India
- Bengaluru, India
- Catanzaro, Italy
- Florence, Italy
- Milan, Italy
- Skopje, North Macedonia
- Belgrade, Serbia
- Madrid, Spain
- Seville, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Dallas, Texas, United States; Zagreb, Croatia; Helsinki, Finland; Nantes, France; Tours, France; Berlin, Germany and 11 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.