Prospective, Non-interventional Study to Evaluate Immunogenicity of AryoSeven

NCT03372993 | Completed

• 1 other identifier: ARY2016-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates the immunogenicity of the biosimilar rFVIIa (AryoSeven) in subjects receiving AryoSeven in real-life clinical practice.

Conditions

Hemophilia A With Inhibitor; Hemophilia B With Inhibitor; Factor VII Deficiency; Glanzmann's Thrombasthenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse Drug Reactions

  Adverse Drug Reactions will be monitored throughout the trial, from patient inclusion up to 12 months follow-up.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 and are negative at immunogenicity testing (antibodies neutralizing FVII).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AryoGen Pharmed Co.: lead

Study Sites (2)

Iranian Blood Transfusion Organization (IBTO)

Tehran, Iran

Location

MAHTA (Iranian Hemophilia and Thrombophilia Association)

Tehran, Iran

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma for PT based Bethesda assay.

MeSH Terms

Conditions

Factor VII Deficiency; Thrombasthenia

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Blood Platelet Disorders

Study Officials

• Mohammad Faranoush, MD

  Hazrat Rasool Akram Hospital, MAHAK Children's Hospital, Iran University of Medical Sciences, Tehran

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 14, 2017
• Study Start: June 13, 2016
• Primary Completion: March 1, 2021
• Study Completion: April 15, 2021
• Last Updated: February 15, 2022

Record last verified: 2020-07

Locations

IR (2)