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Search / Trial NCT05935358

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.

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

0 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