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Purpose

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

Condition

Eligibility

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

Inclusion Criteria

  1. Women/girls with haemophilia A (FVIII:C ≥1-<40%) according to medical history. Additionally, women/girls with documented FVIII activity levels between ≥ 40% and 50% may be included if there is a documented history of clinically significant bleeding episodes consistent with haemophilia A; and/or either documented prior treatment with FVIII concentrates or a clinical indication that FVIII treatment would have been appropriate (e.g., use of FVIII from a family member, or treatment with alternative haemostatic agents due to access limitations) 2. At least 12 years of age 3. Scheduled to undergo major surgery* requiring FVIII treatment, including elective and emergency procedures and caesarean section in pregnant women with haemophilia A 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, except in participants with a planned caesarean section 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 4726206, Texas 4736286 78229

More Details

Status
Recruiting
Sponsor
Octapharma

Study Contact

Cristina Solomon
+41795859042
cristina.solomon@octapharma.com

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.