Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study
Launched by OCTAPHARMA · Jul 3, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called Nuwiq, which is used to help prevent bleeding in male patients with severe Hemophilia A who are undergoing major surgery. These patients are already receiving another treatment called emicizumab to help manage their condition. The trial aims to see how effective Nuwiq is in preventing bleeding during and after surgery for these individuals.
To participate in the study, patients must be male, at least 12 years old, and have a severe form of Hemophilia A. They should have had prior treatment with factor VIII products and must have been on emicizumab for at least one month before their scheduled surgery. Participants will need to give their consent to join the study, and they will be monitored closely during the trial. It’s important to note that some individuals may not be eligible if they have certain medical conditions or have had prior surgeries in this study. Overall, this trial is an important step in finding better ways to manage bleeding risks in patients with Hemophilia A during surgery.
Gender
MALE
Eligibility criteria
- Inclusion 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
- Exclusion Criteria:
- • 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
About Octapharma
Octapharma is a leading global pharmaceutical company specializing in the development and production of human proteins derived from human plasma and recombinant technologies. With a strong commitment to innovation and patient care, Octapharma focuses on creating high-quality therapeutic solutions for various medical conditions, including hematology, immunotherapy, and critical care. The company's extensive research and development efforts are complemented by a robust clinical trial program, aimed at advancing treatment options and improving patient outcomes worldwide. Driven by a dedication to excellence and a collaborative approach, Octapharma continues to make significant contributions to the healthcare industry.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Dallas, Texas, United States
Madrid, , Spain
Zagreb, , Croatia
Helsinki, , Finland
Catanzaro, , Italy
Leeds, , United Kingdom
Tours, , France
Sevilla, , Spain
Bengaluru, , India
Nantes, , France
Duisburg, , Germany
Skopje, , North Macedonia
Florence, , Italy
Belgrade, , Serbia
Berlin, , Germany
Milan, , Italy
Hamburg, , Germany
Vellore, Tamil Nadu, India
Patients applied
Trial Officials
Shveta Gupta, MD
Principal Investigator
Arnold Palmer Hospital for Children
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported