Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT03372993
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03372993
Study Brief:
Protocol Section:
NCT03372993