Trials / Completed
CompletedNCT02962765
Non-interventional Post-authorisation Study to Document the Immunogenicity, Safety, and Efficacy of NUWIQ
Prospective, Multinational, Non-interventional Post-authorisation Study to Document the Long-term Immunogenicity, Safety, and Efficacy of Human-cl rhFVIII (Simoctocog Alfa) in Patients With Haemophilia A Treated in Routine Clinical Practice
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 80 (actual)
- Sponsor
- Octapharma · Industry
- Sex
- Male
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Prospective, multinational, non-interventional post-authorisation study to collect additional clinical data and to ensure consistency in the long-term between the outcome from pre-authorisation clinical studies (in 135 previously treated paediatric and adult patients) and routine clinical practice. Besides aspects such as general product safety and efficacy, there will be a focus on immunogenicity, particularly on inhibitor development. The diagnosis of FVIII inhibitor will be based on clinical observations and confirmed by FVIII inhibitor testing in the laboratory.
Conditions
Timeline
- Start date
- 2015-01-01
- Primary completion
- 2020-08-20
- Completion
- 2020-08-20
- First posted
- 2016-11-11
- Last updated
- 2021-10-21
- Results posted
- 2021-09-28
Locations
39 sites across 13 countries: United States, Argentina, Belarus, Czechia, Ecuador, France, Guatemala, Italy, Lithuania, Norway, Portugal, Slovakia, United Kingdom
Source: ClinicalTrials.gov record NCT02962765. Inclusion in this directory is not an endorsement.