Protocol summary

Summary
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 FVII deficiency. In this study, 66 patients with congenital FVII deficiency 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®.serum level of factor VIIa (FVII:C), frequency and severity of bleeding episodes will be measured before and after the intervention and compared between the groups

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201104266302N1
Registration date: 2011-05-23 19:16:24
Registration timing: prospective
Registration date
2011-05-23, 1390/03/02
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 Biopharma Company
Expected recruitment start date
2012-02-07, 1390/11/18
Expected recruitment end date
2012-05-09, 1391/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Scientific title
Efficacy analysis of Recombinant factor VIIa (Aryogen) in Comparison with Novoseven® on patients with congenital FVII deficiency
Public title
The comparison of efficacy between Novoseven® and Recombinant factor VIIa (Aryogen)
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 2 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
None
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
Country
Iran (Islamic Republic of)
Postal code
14665-1157
Approval date
2011-05-02, 1390/02/12
Ethics committee reference number
ب/394

Health conditions studied

1

Description of health condition studied
congenital FVII deficiency
ICD-10 code
D68.2
ICD-10 code description
Hereditary deficiency of other clotting factors

Primary outcomes

1

Description
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 outcomes

1

Description
frequency of bleeding episodes
Timepoint
initially and one month after starting prophylactic therapy
Method of measurement
clinically,by the hematologist detection

2

Description
Amplitude of probable side effects
Timepoint
Weekly 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:30µ g/kg once per week for one month as prophylactic therapy
Category
Treatment - Drugs

2

Description
in control group Novoseven® is injected to patients at below style:30µ g/kg once per week for one month as prophylactic therapy
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Iranian Blood Transfusion Organization
Full name of responsible person
Dr. Mohammad Faranoush,Professor of Pediatric Hematology & Oncology
Street address
IBTO bldg, Hemmat Exp.Way, Next to the Milad Tower, Tehran, Iran
City
Tehran
Country
Iran (Islamic Republic of)

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
Tehran
Country
Iran (Islamic Republic of)
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
Tehran
Country
Iran (Islamic Republic of)
Postal code
3164819711
Phone
00982616101568-72 ,00982616102587
Fax
+98 26 1610 4644
Email
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
Country
Iran (Islamic Republic of)
Postal code
14665-1157
Phone
+98 218860150130
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
Tehran
Country
Iran (Islamic Republic of)
Postal code
3164819711
Phone
00982616101568-72 ,00982616102587
Fax
+98 26 1610 4644
Email
Email:kamyark@aryogen.com
Web page address
www.aryogen.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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