Comparing the Safety and Efficacy of Recombinant Factor VIII of Saman daroo 8 Pharmaceutical Company(Safacto) with Plasma-derived Factor VIII

Study on Safety and Efficacy of the Recombinant Factor VIII of Saman daroo 8 Pharmaceutical Company (Safacto) in Comparing with Plasma-derived Factor VIII 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

IRCT2014082018870N1

Enrollment

Registered

2014-09-22

Start date

2013-08-22

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: Intevention 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

so every patient receives recombinant factor VIII Safacto, 2 times and plasma-derived factor VIII, 2 times. Intervention 2: control group : plasma-derived factor VIII,Hemoctin SHD 500unites vials,whic

so every patient receives recombinant factor VIII Safacto, 2 times and plasma-derived factor VIII, 2 times.

Treatment - Drugs

Intevention 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 millig

control group : plasma-derived factor VIII,Hemoctin SHD 500unites vials,which were injected in bleeding time in patients with the dosage of 40-50 milligram per kilogram of body weight ,single dose. ea

so every patient receives recombinant factor VIII Safacto, 2 times and plasma-derived factor VIII, 2 times

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Inclusion criteria : patients with sever hemophilia A; without inhibitors against factor VIII; recieving factor VIII for more than 50 days; biochemical blood test should be in the normal range; patients with acute or subacute hemarthrosis exclusion criteria: patients with the history of factor VIII inhibitors; patients with the history of other coagulation disorders except hemophilia; patients with the history of 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
Bleeding. Timepoint: 3 hours. Method of measurement: hemarthrosis diagnosed by the physician.;Reducing pain and improving the motion rate of joints. Timepoint: 1,3,8,12,16 and 24 hours after injection of factor 8. 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