The pharmacokinetic study of AryoSeven with Novoseven in Patients with Congenital Factor VII Deficiency

Phase 3

• Conditions: Hereditary deficiency of factor VII.; Hereditary deficiency of other clotting factors; D68.2

• Registration Number: IRCT2016120231193N1
• Lead Sponsor: AryoGen Pharmed

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 8 March 2022

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Patients with a confirmed diagnosis of congenital, severe Factor VII deficiency (FVII <1%), with >2 episodes of bleeding/year requiring treatment with FVII infusions, in non-bleeding status.
Male and female subjects
Adult and children (>12 years)
Patients to be enrolled must also provide voluntary written informed consent to the protocol to be eligible for the study. For minor patients, parent/legal guardian will provide consent and, when possible, patient assent will also be obtained. For compromised patients, their designated proxy must provide informed consent.
Patients in the Pharmacokinetic (PK) phase will be hospitalized at time of study medication administration and plasma sampling (2 times during the study).

Exclusion Criteria

Any other type of congenital or acquired coagulopathy (except congenital Factor VII deficiency), such as: liver disease (hepatitis), vitamin k deficiency, uremia, malignancy.
Antibodies against Factor VII
Patients entering the PK Phase who have not suspended prophylactic regime with Novoseven or AryoSeven 3 days before starting the trial (receiving first dose of study medication).
Platelet count less than 100.000 platelets/mcL (at screening visit)
Patients who have received routine (prophylactic) treatment with rFVIIa in the period between screening visit (visit 1) and visit 2 of this study (first dose administration)
Any clinical sign or known history of arterial thrombotic event or deep venous- thrombosis or pulmonary embolism
HIV positive with current CD4+ count of less than 200/µL
Liver cirrhosis
Known hypersensitivity to the study medication
Parallel participation in another experimental drug trial.
Parallel participation in another marketed drug trial that may affect the primary end point of the study.

Study & Design

• Study Type: interventional
• Study Design: Not specified