The objective of this randomized, double blind trial is to compare the efficacy of Novoseven® and Recombinant factor VIIa (Aryogen) on the patients with congenital hemophilia A/B with inhibitors,. In this study, 66 patients with congenital hemophilia A/B with inhibitors who meet the inclusion/exclusion criteria will be recruited and randomly assigned into two interventions or a control group. The patients in the intervention group will receive Recombinant factor VIIa (Aryogen) and in the control group will receive Novoseven®. Pain relief, improvement in joint mobility, serum level of factor VIIa (FVII:C) will be measured before and after the intervention and compared between the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202106302N2
Registration date:2012-03-03, 1390/12/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-03, 1390/12/13
Registrant information
Name
Kamran Kamyar
Name of organization / entity
AryoGen Biopharma Company
Country
Iran (Islamic Republic of)
Phone
00982616102587،00982616101568
Email address
kamyark@aryogen.com
Recruitment status
Recruitment complete
Funding source
Aryogen Pharmaceutical company
Expected recruitment start date
2012-02-19, 1390/11/30
Expected recruitment end date
2012-04-29, 1391/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy analysis of Recombinant factor VIIa (Aryogen) in Comparison with Novoseven® on patients with congenital hemophilia A/B with inhibitors
Public title
Efficacy analysis of Recombinant factor VIIa (Aryogen) in Comparison with Novoseven® on patients with congenital hemophilia A/B with inhibitors
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 2 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iranian blood tranfusion organization
Street address
IBTO bldg, Hemmat Exp.Way, Next to the Milad Tower, Tehran, Iran
City
tehran
Postal code
14665-1157
Approval date
2011-05-02, 1390/02/12
Ethics committee reference number
395/ب
Health conditions studied
1
Description of health condition studied
congenital hemophilia A/B with inhibitors
ICD-10 code
D66, D67
ICD-10 code description
Hereditary factor VIII deficiency, Hereditary factor IX deficiency
Primary outcomes
1
Description
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)
2
Description
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)
Secondary outcomes
1
Description
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
2
Description
Amplitude of probable side effects
Timepoint
during therapy and monthly until 3 months after therapy
Method of measurement
clinically, by the hematologist
Intervention groups
1
Description
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
Category
Treatment - Drugs
2
Description
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
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Blood Transfusion Organization
Full name of responsible person
Dr. Mohammad Faranoush
Street address
IBTO bldg, Hemmat Exp.Way, Next to the Milad Tower, Tehran, Iran
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
AryoGen Biopharma Company
Full name of responsible person
Dr. Behrouz Vaziri, general manager
Street address
Cross Tajbakhsh Street, 24th Kilometer Makhsous, Tehran - Iran . AryoGen Biopharma Co
City
Garmdareh
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
AryoGen Biopharma Company
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
AryoGen Biopharma Company
Full name of responsible person
Dr. Kamran Kamyar
Position
General Practitioner/ Medical Manager
Other areas of specialty/work
Street address
Cross Tajbakhsh Street, 24th Kilometer Makhsous, Tehran - Iran . AryoGen Biopharma Co.
City
Garmdareh
Postal code
3164819711
Phone
+98 26 1610 1568
Fax
+98 26 1610 4644
Email
kamyark@aryogen.com
Web page address
www.aryogen.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian Blood Transfusion Organization
Full name of responsible person
Dr. Mohammad Faranoush
Position
Pediatric Hematologist Oncologist Associate Professor
Other areas of specialty/work
Street address
IBTO bldg, Hemmat Exp.Way, Next to the Milad Tower, Tehran, Iran
City
tehran
Postal code
14665-1157
Phone
+98 21 8860 1501
Fax
+98 21 8860 1555
Email
Email:faranoush47@gmail.com
Web page address
http://www.ibto.ir
Person responsible for updating data
Contact
Name of organization / entity
AryoGen Biopharma Company
Full name of responsible person
Dr. Kamran Kamyar
Position
General Practitioner/ Medical Manager
Other areas of specialty/work
Street address
Cross Tajbakhsh Street, 24th Kilometer Makhsous, Tehran - Iran . AryoGen Biopharma Co.
City
Garmdareh
Postal code
3164819711
Phone
+98 26 1610 1568
Fax
+98 26 1610 4644
Email
kamyark@aryogen.com
Web page address
www.aryogen.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)