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Observational Study of Nuwiq, Octanate, and Wilate for Severe Hemophilia A

This international observational study is looking at how well and how safely three specific medicines – Nuwiq, Octanate, and Wilate – work in real-life situations for people with severe hemophilia A (a bleeding disorder where your blood doesn't clot properly). It focuses on patients who haven't been treated before or have only received very little treatment. The study wants to see how often bleeding episodes (breakthrough bleeds) occur while on these medicines and if there are any side effects. You could be eligible if you have severe hemophilia A (FVIII:C<1%) and your doctor has decided to prescribe one of these Octapharma medicines. The study is currently collecting information from about 200 participants.

Study design
This is an international, observational study, meaning researchers will collect information about how these medicines are used in routine care. It aims to enroll about 200 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes, like breakthrough bleeds and adverse drug reactions, are measured at 100 exposure days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03695978

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

Recruiting
Not specifiedAll AgesObservational
Octapharma
~200 participants
Updated 2026-06-02 on ClinicalTrials.gov

At a glance

Recruiting sites
33 of 59 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Annualised rate of breakthrough bleeds to assess efficacy in prophylactic treatment
Measured over 100 exposure days
+1 more outcome measured

Conditions

Haemophilia A

Explore related trials

Hemophilia A

Where it's being run

59 sites across 24 states
Italy11
France8
Germany5
Spain5
Mexico4
Belgium3
United Kingdom3
Belarus2

Study leadership

  • Sigurd Knaub, PhD · STUDY_DIRECTOR · Octapharma

Who to contact

Cristina Solomon, MD
[email protected]
+41 79 585 90 42
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Annualised rate of breakthrough bleeds to assess efficacy in prophylactic treatment100 exposure days

    Annualised rate of all bleeding events (BEs), including all spontaneous, traumatic and joint BEs

  • Incidence of Adverse Drug Reactions (ADRs)100 exposure days

    Adverse drug reactions (ADRs) including hypersensitivity reactions will be recorded in by patients in treatment diaries, which will be reviewed at each Follow-up Visit.