congenital FVII deficiency. Hereditary deficiency of other clotting factors
Conditions
Interventions
Intervention 1: in interventional group recombinant factor VIIa (Aryogen) is injected to patients at below style:30µ g/kg once per week for one month as prophylactic therapy. Intervention 2: in contro
Treatment - Drugs
in interventional group recombinant factor VIIa (Aryogen) is injected to patients at below style:30µ g/kg once per week for one month as prophylactic therapy
in control group Novoseven® is injected to patients at below style:30µ g/kg once per week for one month as prophylactic therapy
Sponsors
AryoGen Biopharma Company
Eligibility
Sex/Gender
All
Age
2 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria:known case of congenital FVII deficiency that frequency of his/her bleeding episodes more than one per month,age older than 2,gender: male or female,proper IV line for drug injection,Exclusion criteria: Presence of any congenital or acquired coagulopathy disorders except for congenital F VII deficiency, liver disease (hepatitis), uremia, malignancy, vitamin K deficiency, having received Novoseven® as prophylactic therapy in congenital FVII deficiency since one month ago,severe atherosclerotic disease,any local pathology that predisposes the patient to bleeding, presence of antibody against FVII,Platelet count lower than 50000
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum level of factor VIIa (FVII:C). Timepoint: in time zero(immediately befor injection) and 20 minutes after each injection. Method of measurement: by ELISA labratory test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of bleeding episodes. Timepoint: initially and one month after starting prophylactic therapy. Method of measurement: clinically,by the hematologist detection.;Amplitude of probable side effects. Timepoint: Weekly during therapy and monthly until 3 months after therapy. Method of measurement: clinically, by the hematologist. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Kamran Kamyar
AryoGen Biopharma Company
Outcome results
None listed