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New treatment option for Hemophilia A
Official title Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery
ClinicalTrials.gov ID: NCT05936580
What this study is testing
What is Nuwiq?
Nuwiq is an investigational medicine, being studied as a potential treatment for hemophilia a.
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
- Recombinant factor VIII for the prevention of bleeding in women/girls with haemophilia A undergoing major surgery
- 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, women only
You may be able to join if
- Women/girls with haemophilia A (FVIII:C ≥1-\<40%) according to medical history. Additionally, women/girls with documented FVIII activity levels...
- At least 12 years of age
- Scheduled to undergo major surgery\ requiring FVIII treatment, including elective and emergency procedures and caesarean section in pregnant women...
- 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)
- Severe liver or kidney disease (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] levels \>5 times the upper limit of normal; or...
- Known hypersensitivity to Nuwiq's active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride...
- Pregnancy, except in participants with a planned caesarean section
- Already had surgery in this study
See the full eligibility criteria
- Women/girls with haemophilia A (FVIII:C ≥1-\<40%) according to medical history. Additionally, women/girls with documented FVIII activity levels between ≥ 40% and 50% may be included if there is a documented history of...
- At least 12 years of age
- Scheduled to undergo major surgery\ requiring FVIII treatment, including elective and emergency procedures and caesarean section in pregnant women with haemophilia A
- 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)
- 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)
- Pregnancy, except in participants with a planned caesarean section
- 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's taking place
- San Antonio, Texas, United States
- Helsinki, Finland
- Chambray-lès-Tours, France
- Nantes, France
- Stasbourg, France
- Bonn, Germany
- Duisburg, Germany
- Hamburg, Germany
- Catanzaro, Italy
- Palermo, Italy
- Belgrade, Serbia
- Madrid, Spain
- Seville, Spain
- Bern, Switzerland
- Leeds, United Kingdom
- Montevideo, Uruguay
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 - 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 female, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Antonio, Texas, United States; Helsinki, Finland; Chambray-lès-Tours, France; Nantes, France; Stasbourg, France; Bonn, Germany and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.