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Recruiting NCT03695978

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

Trial Parameters

Condition Haemophilia A
Sponsor Octapharma
Study Type OBSERVATIONAL
Phase N/A
Enrollment 200
Sex ALL
Min Age N/A
Max Age N/A
Start Date 2018-02-13
Completion 2030-06

Brief Summary

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.

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 treatme

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