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Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients
Practical Utilisation of Octapharma FVIII Concentrates in Previously Untreated & Minimally Treated Haemophilia A Patients Entering Routine Clinical Treatment With Nuwiq, Octanate or Wilate - Efficacy & Safety Observational Study-Protect-NOW
Who can join
All ages · All sexes
Full eligibility criteria
Inclusion Criteria: * Male and female patients of any age and ethnicity * Severe haemophilia A (FVIII:C\<1%) * Decision to prescribe Octapharma's FVIII concentrate before enrollment into the study * Either * No previous treatment with FVIII concentrates or other blood products containing FVIII (PUPs) OR * Less than 5 Exposure Days (EDs) to FVIII concentrates or other blood products containing FVIII (MTPs), if * data are available on all previous treatment, AND * they did not develop an inhibitor at any time point, OR * they developed an inhibitor during treatment with an Octapharma FVIII concentrate AND continue treatment with THIS Octapharma FVIII concentrate (in the presence or absence of emicizumab). * Voluntarily given, fully informed written and signed consent obtained before any study-related data documentation is conducted (obtained from the patient's parent/legal guardian) Exclusion Criteria: * Diagnosis with a coagulation disorder other than haemophilia A * Concomitant treatment with any systemic immunosuppressive drug * Participation in an interventional clinical trial during the time period evaluated * Participation in another non-interventional study of Octapharma
About the study
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.
Sponsor: Octapharma · Participants: 200 · Started: Feb 13, 2018
Contact the study team
- Cristina Solomon, MD · Phone: +41 79 585 90 42
Official record on ClinicalTrials.gov — NCT03695978
Locations in the U.S.
| Florida | University of Miami Miller School of Medicine, Miami |
| Missouri | St. Louis University , 221 North Grand Boulevard, St Louis (Not yet recruiting) |
| Texas | The University of Texas Health Science Center at San Antonio, San Antonio (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.