Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study

Description

Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis

Conditions

Severe Hemophilia A

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Study Overview

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Study Details

Study overview

Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis

Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study (NuPOWER)

Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study

Condition
Severe Hemophilia A
Intervention / Treatment

-

Contacts and Locations

Dallas

UT Southwestern Medical Center, Dallas, Texas, United States, 75390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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 interventional clinical trial
  • * Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit

Ages Eligible for Study

12 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Octapharma,

Shveta Gupta, MD, PRINCIPAL_INVESTIGATOR, Arnold Palmer Hospital for Children

Study Record Dates

2025-12