Clinical Trial Details
— Status: Completed
Administrative data
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 |
Study information
Verified date |
July 2020 |
Source |
AryoGen Pharmed Co. |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
This study evaluates the immunogenicity of the biosimilar rFVIIa (AryoSeven) in subjects
receiving AryoSeven in real-life clinical practice.
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.