A prospective Crossover Triple-blind Controlled Trial on the Safety and Efficacy of Iranian Recombinant FVIII (Safacto) versus Plasma Derived FVIII A pilot study
Journal Title: Iranian Journal of Blood and Cancer - Year 2015, Vol 7, Issue 4
Abstract
Background: Considering the increasing number of patients with hemophilia and infrastructure requirements for a comprehensive approach, development of a recombinant factor has become a milestone. The objective of this study was to assess the safety, efficacy and non inferiority of Safacto (Recombinant factor VIII) compared with plasma-derived factor in the treatment of hemophilia A. Methods: 10 patients with severe hemophilia A were enrolled in this study. Each patient was treated by a 40-50 IU/kg infusion of either plasma derived or recombinant factor VIII after initiation of each of 4 consecutive hemarthrosis episodes in a triple-blind prospective crossover permuted block randomizing method. Clinical efficacy scale score and in vivo recovery of factor VIII was assessed in each of the treated bleeding episodes. Any adverse event was also recorded. Results: The mean±SD level of factor VIII in the plasma versus recombinant groups was 111.5±39 and 115±39, respectively without any significant difference. Response scaling method which assessed pain and range of motion revealed equalized scores along with in vivo recovery, hence treatment success rate was comparable in both groups. One non-recurring, mild skin rash reaction occurred simultaneous with the administration of plasma derived factor. Conclusion: Safacto (r-FVIII) is safe and effective and non-inferior to plasma derived factor VIII in the treatment of hemophilia A related bleeding events.
Authors and Affiliations
Peyman Eshghi, Hassan Abolghasemi, Fatemeh Malek, Majid Naderi, Yunes Panahi, Behnaz Habibpanah, E Fatohlahzadeh, F Gorji
Keywords
Related Articles
- EP ID EP281501
- DOI -
- Views 79
- Downloads 0
Difficulties in Diagnosis of Hemophagocytic Lymphohistocytosis: Overdiagnosis or Underdiagnosis A Case Report
This article has no abstract.
Breast Cancer Associated with Dermatomyositis
Dermatomyositis (DM) is a rare idiopathic inflammatory myopathy with characteristic skin lesions. Case series have shown an association between dermatomyositis and malignancy. Malignancy has been found in 15-25% of the a...
Kaposiform Hemangioendothelioma in a Newborn with Kasabach-Merritt Syndrome
This article has no abstract.
Association between Urban Benzene Pollution and Incidence of Acute Myeloid Leukemia
Background: Benzene has been classified as group 1 human carcinogens in the environment by the International Agency for Research on Cancer (IARC) mainly because of its ability to cause acute myeloid leukemia (AML). This...
Therapeutic Plasma Exchange in Pediatric Severe Immune Thrombocytopenia: A Case Report and Literature Review
Treatment of severe Immune Thrombocytopenic purpura (ITP) accompanied by life-threatening bleeding events is challenging and a combination of treatment measures should be undertaken to rapidly increase the platelet count...