Prospective, Non-interventional Study to Evaluate Immunogenicity of AryoSeven (NCT03372993) | Clinical Trial Compass
CompletedNot Applicable
Prospective, Non-interventional Study to Evaluate Immunogenicity of AryoSeven
Iran200 participantsStarted 2016-06-13
Plain-language summary
This study evaluates the immunogenicity of the biosimilar rFVIIa (AryoSeven) in subjects receiving AryoSeven in real-life clinical practice.
Who can participate
SexALL
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Inclusion Criteria:
* Patients with Hemophilia A or B with inhibitors, Factor VII Deficiency, Glanzmann's thrombasthenia
* Treated with AryoSeven in the daily practice,
* Signed informed consent (parents for children).
* an immunogenicity test negative, performed at the earliest time after NovoSeven was no longer available in Iran. Patients who do not have a previous negative immunogenicity test should be enrolled if negative at immunogenicity test performed during screening for this study.
Exclusion Criteria:
* Patients who received NovoSeven for any indication at any time before inclusion in the study, until an immunogenicity test excluded the development of immunogenicity related to NovoSeven.
* Parallel participation in another experimental drug trial.
* Parallel participation in another marketed drug trial (except for AryoSeven) that may affect the immunogenicity endpoint of the study.