Status:
COMPLETED
Prospective, Non-interventional Study to Evaluate Immunogenicity of AryoSeven
Lead Sponsor:
AryoGen Pharmed Co.
Conditions:
Hemophilia A With Inhibitor
Hemophilia B With Inhibitor
Eligibility:
All Genders
Brief Summary
This study evaluates the immunogenicity of the biosimilar rFVIIa (AryoSeven) in subjects receiving AryoSeven in real-life clinical practice.
Detailed Description
This is a Non-interventional, observational, prospective evaluation of immunogenicity (neutralizing antibodies toward FVII) of patients with Hemophilia A or B with inhibitors, Factor VII Deficiency, G...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 13 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 15 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03372993
Start Date
June 13 2016
End Date
April 15 2021
Last Update
February 15 2022
Active Locations (2)
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1
Iranian Blood Transfusion Organization (IBTO)
Tehran, Iran
2
MAHTA (Iranian Hemophilia and Thrombophilia Association)
Tehran, Iran