Comparative study of filgrastim and pegfilgrastim effect in the treatment of fever and neutropenia in patients with leukemia
Design
In this study, 120 patients with leukemia referred to Mohammad Kermanshahi Hospital in Kermanshah city who are eligible for inclusion in the study will be selected conveniently and randomly will be assigned into two intervention groups and each participant will be assigned a code.
Settings and conduct
This study will be conducted as a single blind clinical trial, by a research assistant at the Mohammad Kermanshahi Hospital . In this way that participants do not know which intervention group will be assigned to and which medication they will receive.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients suffering from leukemia who have fever and neutropenia (NAC less than 1500)
Exclusion criteria: Neutropenic patients other than leukemia; patients who have not received the full course of treatment
Intervention groups
The first intervention group will receive ten micro gram per kilogram filgrastim for three days for treatment of neutropenia , and the second intervention group will receive one tenth micro gram per kilogram of pegfilgrastim in single dose form
Main outcome variables
Fever and neutropenic levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N80
Registration date:2017-12-22, 1396/10/01
Registration timing:registered_while_recruiting
Last update:2017-12-22, 1396/10/01
Update count:0
Registration date
2017-12-22, 1396/10/01
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-09-01, 1396/06/10
Expected recruitment end date
2017-12-31, 1396/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of filgrastim and pegfilgrastim effect in the treatment of fever and neutropenia in patients with leukemia
Public title
The effect of filgrastim and pegfilgrastim in the treatment of fever and immune deficiency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with leukemia, suffering from fever and neutropenia (NAC less than 1500)
Exclusion criteria:
Neutropenic patients other than leukemia
patients who have not received the full course of treatment
Age
From 1 year old to 10 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by coin tossing (throwing a coin).
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, participants will not be informed about which intervention group they will be assigned to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2017-02-26, 1395/12/08
Ethics committee reference number
KUMS.REC.1395.764
Health conditions studied
1
Description of health condition studied
Ischemic stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Fever
Timepoint
At the beginning of the study, every other day until fever is stopped
Method of measurement
Using the Thermometer
2
Description
Neutropenia
Timepoint
At the beginning of the study, every other day until the ANC reaches over 1500
Method of measurement
Based on laboratory kits and based on the results of blood tests
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive ten micro gram per kilogram Filgrastim (produced by Cinnagen pharmaceutical company) in the form of intramuscular injection for three days
Category
Treatment - Drugs
2
Description
Intervention group 2 will receive 0.1 micro gram per kilogram Pegfilgrastim (produced by Cinnagen pharmaceutical company) in a single dose intramuscular injection
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohammad Kermanshahi Hospital
Full name of responsible person
Dr. Mohamad hosseyn Rasoli
Street address
Mohammad Kermanshahi Hospital, Helala Ahmar Crossroads
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6301
Email
M-Rcolpayecani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hosseyn Rasoli
Position
Resident in training, children's specialty
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Mohammad Kermanshahi Hospital, Helala Ahmar Crossroads
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3025 0285
Fax
Email
m.rasoli@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Golpaygani
Position
Subspecialist in Blood and oncology
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Mohammad Kermanshahi Hospital, Helala Ahmar Crossroads
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3025 0285
Fax
Email
M-Rcolpayecani@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohammad hosseyn Rasoli
Position
Resident in training, children's specialty
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Mohammad Kermanshahi Hospital, Helala Ahmar Crossroads
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3025 0285
Fax
Email
m.rasoli@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main result of the study will be shared.
When the data will become available and for how long
3 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail