Comparing the Safety and Efficacy of Recombinant Factor VIII of Saman daroo 8 Pharmaceutical Company(Safacto) with Plasma-derived Factor VIII
Phase 3
- Conditions
- hemophilia A.Hereditary factor VIII deficiency
- Registration Number
- IRCT2014082018870N1
- Lead Sponsor
- Saman daroo 8 Pharmaceutical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 6
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
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Activity rate of factor VIII. Timepoint: befor and 15 minutes after injection of factor VIII. Method of measurement: assessed by ELISA kit.