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

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Octapharma
Study ID
NCT05936580
Phase
PHASE4
Status
Recruiting
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Conditions

  • Hemophilia A

Eligibility Criteria

Sex
FEMALE
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nuwiq — DRUG
    Nuwiq is a purified B-domain-deleted FVIII glycoprotein synthesised by a genetically engineered human embryonic kidney cell line (HEK 293F).

Study Details

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

Key Dates

Start date
Apr 30, 2026
Status verified
Jan 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Overall haemostatic efficacy [ Time Frame: During surgery and until completion of wound healing (e.g. removal of sutures, cessation of drainage, etc.) as defined by the investigator, during the study duration of 30 ± 3 days after the day of surgical procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Health San AntonioSan AntonioTexas78229-

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UT Health San Antonio· San Antonio, TX

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