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

Purpose

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

Condition

  • Hemophilia A

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion 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

Exclusion Criteria

  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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Nuwiq 		All patients receiving Nuwiq (recombinant FVIII). Nuwiq will be administered intravenously in accordance with the relevant prescribing information. Treatment will be repeated as necessary every 8-24 hours until adequate wound healing, then - if required - for at least another 7 days to maintain FVIII plasma levels of 30-60 IU/dL.
  • Drug: Nuwiq
    Nuwiq is a purified B-domain-deleted FVIII glycoprotein synthesised by a genetically engineered human embryonic kidney cell line (HEK 293F).

Recruiting Locations

UT Health San Antonio
San Antonio, Texas 78229

More Details

Status
Recruiting
Sponsor
Octapharma

Study Contact

Sigurd Knaub
+41 554512141
Sigurd.Knaub@octapharma.ch

Detailed Description

Female patients with mild to moderate haemophilia A will often need FVIII concentrates to provide haemostatic cover during major surgery. This prospective, open-label, non-controlled, single-arm, multinational, multicentre study aims to evaluate the overall perioperative haemostatic efficacy of Nuwiq in women/girls over 12 with haemophilia A undergoing major surgery requiring FVIII treatment