An observational study in Haemophilia A, sponsored by Octapharma. Recruiting at 59 sites in 18 countries. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Octapharma · Observational
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.
Octapharma's FVIII concentrates have been tested in clinical trials and registered for treatment of haemophilia A; however, as haemophilia A is a rare disease, the numbers of patients treated in studies so far are limited. For previously untreated patients (PUPs), who are typically young children, and for minimally treated patients (MTPs), who have been exposed to only minimal FVIII dosages, there is a general interest to increase the body of data on treatment effectiveness and safety, particularly related to inhibitor development. Also, specifically for PUPs, treatment algorithms are not standardized, e.g. with respect to utilisation, dosage, frequency or optimal start age of FVIII prophylaxis. Real world evidence derived from a non-interventional study (NIS) can describe product utilisation and demonstrate value over a product's life cycle and facilitate benefit-risk assessments. The purpose of this study is thus to evaluate product utilisation, effectiveness and safety, including inhibitor development information, in severe haemophilia A PUPs and MTPs, who have been prescribed Octapharma's FVIII concentrates.
844 studies on the registry are indexed under Hemophilia A; 138 are open to participants now.
This study's planned enrollment of 200 is above the median of 81 across 310 observational studies indexed under Hemophilia A.
Browse Hemophilia A studies →Octapharma is the lead sponsor of 71 studies on the registry; 8 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 16 (94%) have results posted.
Counted across the registry records on this site, refreshed daily.
A total of 200 patients, either previously untreated patients (PUPs) or minimally treated patients (MTPs), are planned to be documented in the study
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients receiving Nuwiq (recombinant FVIII)
All patients receiving Octanate (plasma derived FVIII)
All patients receiving Wilate (plasma derived FVIII/von Willebrand factor \[VWF\])
Annualised rate of breakthrough bleeds to assess efficacy in prophylactic treatment
Annualised rate of all bleeding events (BEs), including all spontaneous, traumatic and joint BEs
Time frame: 100 exposure days
Incidence of Adverse Drug Reactions (ADRs)
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.
Time frame: 100 exposure days
Dosage of FVIII concentrates
For each individual FVIII injection the dose will be recorded.
Time frame: 100 exposure days
Overall assessment of the effectiveness of surgical prophylaxis by the treating physicians
At the end of the postoperative period, treating physicians will assess the effectiveness of surgical prophylaxis using a scale including the four items: 'excellent,' 'good,' moderate,' and 'none'.
Time frame: 100 exposure days
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