At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Nuwiq (drug)
- How long the study runs
- Study runs about 34 months (dates as stated)
- About the drug or intervention
- Nuwiq — drug: Nuwiq is a purified B-domain-deleted FVIII glycoprotein synthesised by a genetically engineered human embryonic kidney cell line (HEK 293F).
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at Nuwiq, a treatment for severe haemophilia A, in patients who are already having regular preventive treatment with a medicine called emicizumab. It is for people who need major planned surgery that requires treatment with factor eight (a blood-clotting protein). The study is sponsored by Octapharma.
Who can take part
- Males aged 12 or over
- Severe haemophilia A (factor eight activity below 1%) based on medical history
- Have had at least 150 days of previous treatment with factor eight products
- Have been on regular preventive treatment with emicizumab for at least 1 month before planned major surgery that needs factor eight treatment
- Patient, or parent/legal representative, gives written informed consent where required by local rules
Who may not be able to
- Have a blood-clotting disorder other than haemophilia A
- Have now or in the past had factor eight inhibitors (0.6 Bethesda units per millilitre or more) according to medical history
- Severe liver or kidney disease (certain liver enzyme levels more than 5 times the normal limit, or creatinine above 120 micromoles per litre)
- Known allergy to Nuwiq or its ingredients
- Have already had surgery in this study
- Currently taking part in another clinical trial of a treatment
- Have taken any investigational medicine within 30 days before the screening visit
What taking part involves
- • Not stated — ask the trial team
Time commitment: Number of visits and study duration: Not stated — ask the trial team. Taking part involves receiving Nuwiq for factor eight treatment around scheduled major elective surgery while continuing regular emicizumab prophylaxis.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 12 Years and over
- Who
- Male
- Number of participants
- 28
- Started
- 2023-11-28
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for severe hemophilia a
- • Phase4 - 28 participants
- • Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis
Who can take part?
- • Ages 12 Years and over
- • Diagnosed with severe hemophilia a
- • Male only
Where?
- • Leeds - St. James's University Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis
More detail
Patients with severe haemophilia A receiving emicizumab will often need concomitant FVIII to provide haemostatic cover during major surgery. This prospective, open-label, uncontrolled, single-arm, multinational, multicentre study aims to evaluate the overall perioperative haemostatic efficacy of Nuwiq, a recombinant factor VIII, in combination with emicizumab prophylaxis in male patients over 12 with severe haemophilia A undergoing major surgery.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 12 Years and over
- Who can join: Male only
Treatment history
Treatments you must have had:
- ✓ any FVIII product(s) f
What the study is looking for
- ✓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...
- ✓Freely given written agreement to take part of the patient, or parent/legal representative where applicable, obtained in...
Who cannot take part
- ✗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 \[liver enzymes\] and/or aspartate aminotransferase \[liver enzymes\] levels...
- ✗Known hypersensitivity to Nuwiq's active substance or its excipients (sucrose, sodium chloride, calcium chloride...
- ✗Already had surgery in this study
See the full criteria
Where Is This Study? (1 UK site)
St. James's University Hospital
Leeds, United Kingdom
How to Get in Touch
Sigurd Knaub, PhD
Sponsor contactCONTACT