Hemophilia A With Inhibitor Clinical Trial
Official title:
A Post-Marketing, Observational Study in Iran to Determine the Immunogenicity Status in Patients Who Have Received rFVIIa AryoSeven.
NCT number | NCT03372993 |
Other study ID # | ARY2016-01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 13, 2016 |
Est. completion date | April 15, 2021 |
Verified date | July 2020 |
Source | AryoGen Pharmed Co. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study evaluates the immunogenicity of the biosimilar rFVIIa (AryoSeven) in subjects receiving AryoSeven in real-life clinical practice.
Status | Completed |
Enrollment | 200 |
Est. completion date | April 15, 2021 |
Est. primary completion date | March 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Iranian Blood Transfusion Organization (IBTO) | Tehran | |
Iran, Islamic Republic of | MAHTA (Iranian Hemophilia and Thrombophilia Association) | Tehran |
Lead Sponsor | Collaborator |
---|---|
AryoGen Pharmed Co. |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Immunogenicity (neutralising antibodies toward FVII) | Immunogenicity will be assessed with the PT based Bethesda assay. In case of positive results, an inhibitor retesting using a second separately drawn sample as confirmatory measurement will be performed by a different specialised laboratory. | On plasma samples obtained 12 months after patient inclusion. | |
Secondary | Adverse Drug Reactions | Adverse Drug Reactions related to the administration of AryoSeven reported by patients. | Adverse Drug Reactions will be monitored throughout the trial, from patient inclusion up to 12 months follow-up. |
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