Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
Study NCT ID:
NCT03372993
Status:
COMPLETED
Last Update Posted:
2022-02-15
First Post:
2017-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective, Non-interventional Study to Evaluate Immunogenicity of AryoSeven
Sponsor:
AryoGen Pharmed Co.
Organization:
Study Overview
Official Title:
A Post-Marketing, Observational Study in Iran to Determine the Immunogenicity Status in Patients Who Have Received rFVIIa AryoSeven.
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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, Glanzmann's thrombasthenia, who have received one or more dose of AryoSeven in the daily practice. This study is conducted in Iran where AryoSeven is available on the market since 21-8-2012 and NovoSeven is no longer available since 2013. Patients will be retrieved from the Iranian Registry of Hemophilia patients of MATHA (Iranian Hemophilia and Thrombophilia Association, Tehran, Iran). The Registry Patient Screener will sequentially review patients in the Registry to identify patients who have received treatment with AryoSeven, in reverse chronological order of inclusion in the registry, starting from a date 6 months prior to the date of this study and until when the sample size to enroll (200 patients) is completed.
Patients identified will be called for a visit (Screening visit) for providing informed consent, interview, and blood sampling collection for prospective immunogenicity testing. Retrospective data collection, including previous immunogenicity status and the number of exposure days, will be performed on hospital records, patient diary. Immunogenicity will be tested by a centralized laboratory in Iran using the PT-based Bethesda assay.
Patients will be enrolled if they had 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 will be enrolled if negative at immunogenicity test performed during screening for this study.
Patients enrolled will be followed for at least 12 months for immunogenicity and Adverse Drug Reactions.
Patients who have a positive previous immunogenicity test or results positive at immunogenicity test performed at Screening (patients without a previous immunogenicity test), will not be enrolled, but registered and followed for 12 months (or longer) to collect data on the natural history of their disease.
Patients identified will be called for a visit (Screening visit) for providing informed consent, interview, and blood sampling collection for prospective immunogenicity testing. Retrospective data collection, including previous immunogenicity status and the number of exposure days, will be performed on hospital records, patient diary. Immunogenicity will be tested by a centralized laboratory in Iran using the PT-based Bethesda assay.
Patients will be enrolled if they had 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 will be enrolled if negative at immunogenicity test performed during screening for this study.
Patients enrolled will be followed for at least 12 months for immunogenicity and Adverse Drug Reactions.
Patients who have a positive previous immunogenicity test or results positive at immunogenicity test performed at Screening (patients without a previous immunogenicity test), will not be enrolled, but registered and followed for 12 months (or longer) to collect data on the natural history of their disease.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: