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IRCT201202106302N2 IRCT 2012-03-03 AryoGen Biopharma Company Efficacy analysis of Recombinant factor VIIa (Aryogen) in Comparison with Novoseven® on patients with congenital hemophilia A/B with inhibitors Efficacy analysis of Recombinant factor VIIa (Aryogen) in Comparison with Novoseven® on patients with congenital hemophilia A/B with inhibitors 2012-02-19 anticipated 66 Complete https://irct.ir/trial/6751 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 congenital hemophilia A/B with inhibitors. Intervention 1: in interventional group recombinant factor VIIa (Aryogen) is injected to patients at below style:90µ g/kg as start dose then 120µ g/kg every 2 hours for 3 dose. Intervention 2: in control group Novoseven® is injected to patients at below style: 90µ g/kg as start dose then 120µ g/kg every 2 hours for 3 dose.
public Dr. Kamran Kamyar
Cross Tajbakhsh Street, 24th Kilometer Makhsous, Tehran - Iran . AryoGen Biopharma Co.
Garmdareh Iran (Islamic Republic of) 3164819711 +98 26 1610 1568 kamyark@aryogen.com AryoGen Biopharma Company scientific Dr. Mohammad Faranoush
IBTO bldg, Hemmat Exp.Way, Next to the Milad Tower, Tehran, Iran
tehran Iran (Islamic Republic of) 14665-1157 +98 21 8860 1501 Email:faranoush47@gmail.com Iranian Blood Transfusion Organization Iran (Islamic Republic of) Inclusion criteria: known case of congenital hemophilia A/B with inhibitors level more than 5 Bethesda unit, age older than 2 , gender male or female, proper IV line for drug injection, the severity of bleeding should be evaluable Exclusion criteria: Presence of any congenital or acquired coagulopathy disorders except for congenital hemophilia A/B with inhibitors such as:( liver disease (hepatitis), uremia, malignancy, vitamin K deficiency) , severe atherosclerotic disease, any local pathology that predisposes the patient to bleeding, having been under immune tolerance induction therapy during one month prior to the study, Platelet count lower than 50000 2 years 80 years Both D66, D67 Hereditary factor VIII deficiency, Hereditary factor IX deficiency Treatment - Drugs Treatment - Drugs in interventional group recombinant factor VIIa (Aryogen) is injected to patients at below style:90µ g/kg as start dose then 120µ g/kg every 2 hours for 3 dose in control group Novoseven® is injected to patients at below style: 90µ g/kg as start dose then 120µ g/kg every 2 hours for 3 dose Pain intensity. Timepoint: 1,3,6,9 hours after first injection(according to Kavakli global response scoring system). Method of measurement: clinically,by the hematologist(according to Kavakli global response scoring system). Joint mobility. Timepoint: 1,3,6,9 hours after first injection(according to Kavakli global response scoring system). Method of measurement: clinically,by the hematologist detection (according to Kavakli global response scoring system). Serum level of factor VIIa (FVII:C). Timepoint: in time zero(immediately befor injection) and 20 minutes after first injection. Method of measurement: by ELISA labratory test. Amplitude of probable side effects. Timepoint: during therapy and monthly until 3 months after therapy. Method of measurement: clinically, by the hematologist. AryoGen Biopharma Company Approved 2011-05-02 Iranian blood tranfusion organization IBTO bldg, Hemmat Exp.Way, Next to the Milad Tower, Tehran, Iran tehran Iran (Islamic Republic of)