Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients

Part of paid clinical trials in Miami, Florida.

Sponsor
Octapharma
Study ID
NCT03695978
Status
Recruiting
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Conditions

  • Haemophilia A

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Study Details

International, post-authorisation non-interventional study to evaluate real-life effectiveness, safety and utilisation patterns of Octapharma's FVIII concentrates Nuwiq, Octanate, and Wilate in previously untreated and minimally treated severe haemophilia A patients in routine clinical practice.

Key Dates

Start date
Feb 13, 2018
Status verified
Nov 2025
Primary completion
Jun 30, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Nuwiq
    All patients receiving Nuwiq (recombinant FVIII)
  • Arm: Octanate
    All patients receiving Octanate (plasma derived FVIII)
  • Arm: Wilate
    All patients receiving Wilate (plasma derived FVIII/von Willebrand factor \[VWF\])

Primary Outcome Measure

Annualised rate of breakthrough bleeds to assess efficacy in prophylactic treatment [ Time Frame: 100 exposure days ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of Miami Miller School of MedicineMiamiFlorida33136-
Ochsner Clinic FoundationNew OrleansLouisiana70121-
St. Louis University , 221 North Grand BoulevardSt LouisMissouri63103-
Cure 4 The Kids Foundation Children's Specialty CenterLas VegasNevada89109-
The University of Texas Health Science Center at San AntonioSan AntonioTexas78712-

Find similar trials in Miami, FL

By research site
University of Miami Miller School of Medicine· Miami, FLOchsner Clinic Foundation· New Orleans, LASt. Louis University , 221 North Grand Boulevard· St Louis, MOCure 4 The Kids Foundation Children's Specialty Center· Las Vegas, NVThe University of Texas Health Science Center at San Antonio· San Antonio, TX

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