Comparing the Safety and Efficacy of Recombinant Factor VIII of Saman daroo 8 Pharmaceutical Company(Safacto) with Recombinant Factor VIII of Pfizer Pharmaceutical Company (Xyntha)

Study on Safety and Efficacy of the Recombinant Factor VIII of Saman daroo 8 Pharmaceutical Company (Safacto) in Comparing with Recombinant Factor VIII of Pfizer Pharmaceutical Company (Xyntha) in Patients with Sever Hemophilia A,Exposing to Factor VIII for More Than 50 Days

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014101218870N2

Enrollment

Registered

2014-10-27

Start date

2014-10-23

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hemophilia A. Hereditary factor VIII deficiency

Interventions

Intervention 1: Intervention group: recombinant factor VIII,produced in Saman daroo 8 pharmaceutical company ( Safacto) 500 unites vials,which were injected in bleeding time in patients with the dosag

Treatment - Drugs

Intervention group: recombinant factor VIII,produced in Saman daroo 8 pharmaceutical company ( Safacto) 500 unites vials,which were injected in bleeding time in patients with the dosage of 40-50 milli

control group:recombinant factor VIII,produced in Pfizer pharmaceutical company ( Xyntha) 500 unites vials,which were injected in bleeding time in patients with the dosage of 40-50 milligram per kilog

Eligibility

Sex/Gender

Male

Age

5 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria : patients with sever hemophilia A; without inhibitors against factor VIII; receiving factor VIII for more than 50 days; patients with acute or sub acute hemarthrosis;72 hours after the last injection of factor VIII exclusion criteria: patients with the history of factor VIII inhibitors; patients with the history of other coagulation disorders except hemophilia; patients with different untreated hepatitis; patients with renal or liver failure; HIV positive patients; patients with any infection; any allergy or severe adverse effect diagnosed by the physician ( observed adverse effects will be recorded and the patient will be excluded from the study); giving up the study

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Pain relief. Timepoint: 1,3,8,12,16,24 hours after treatment. Method of measurement: according to the mentioned questionnaire.;Improving the motion rate of joints. Timepoint: 1,3,8,12,16,24 hours after treatment. Method of measurement: according to the Kavakli questionnaire(global response scoring system).	—

Secondary

Measure	Time frame
Activity rate of factor VIII. Timepoint: befor and 15 minutes after injection of factor VIII. Method of measurement: assessed by ELISA kit.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactYunes Panahi

Baghiyatallah University of Medical Science

yunespanahi@yahoo.com+98 21 8821 1524

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026