Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery

Description

Recombinant factor VIII for the prevention of bleeding in women/girls with haemophilia A undergoing major surgery

Conditions

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 women/girls with haemophilia A undergoing major surgery

Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery - an International, Open-label, Non-controlled Study (NuDIMENSION)

Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery

Condition
Hemophilia A
Intervention / Treatment

-

Contacts and Locations

San Antonio

UT Health San Antonio, San Antonio, Texas, United States, 78229

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

  • 1. Women/girls with haemophilia A (FVIII:C ≥1-\<40%) according to medical history
  • 2. At least 12 years of age
  • 3. Scheduled to undergo major elective surgery requiring FVIII treatment
  • 4. Freely given written informed consent of the patient, or parent/legal representative where applicable, obtained in accordance with local regulations
  • 1. Coagulation disorder other than haemophilia A
  • 2. Present or past FVIII inhibitor (≥0.6 Bethesda units \[BU\]/mL)
  • 3. 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)
  • 4. Known hypersensitivity to Nuwiq's active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188)
  • 5. Pregnancy
  • 6. Already had surgery in this study
  • 7. Current participation in another interventional clinical trial
  • 8. 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

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Octapharma,

Johannes Oldenburg, PRINCIPAL_INVESTIGATOR, Experimental Haematology and Transfusion Medicine, University Clinic Bonn

Study Record Dates

2025-12