The aim of this study is to compare the efficacy of two different drugs in children with neutropenia. Patients with less than 16 years and neutropenia due to leukemia or solid tumor refer to Ali Asghar Hospital blood clinic and department will be enrolled. The patients will be categorized based on the underlying disease to three categories: patients with leukemia and neutropenia follow by chemotherapy, patients with leukemia and neutropenia follow by infection, patients with solid tumor and neutropenia follow by chemotherapy. 11 patients will be selected consecutively from each group and will be treated with filgrastim in the first round of chemotherapy. The same patients will be treated with the pegfilgrastim in next period. Thus, patients in both groups will be same and equal to 33. The filgrastim and pegfilgrastim will injected subcutaneously with a 5-10 µg/kg/day dose to 7 days and a 100 µg/kg as a single dose, respectively. We will check absolute neutrophil count 7 days after the last injection in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205279875N1
Registration date:2014-03-01, 1392/12/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-03-01, 1392/12/10
Registrant information
Name
saeed yousefian
Name of organization / entity
ali asghar hosp.
Country
Iran (Islamic Republic of)
Phone
+98 21 2304 6411
Email address
s_yousefian@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Cinnagen Drug Corporation
Expected recruitment start date
2012-09-01, 1391/06/11
Expected recruitment end date
2014-02-01, 1392/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of effects of Filgrastim and Peg-Filgrastim in neutropenic patients
Public title
The comparison of effects of two drugs in neutropenic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Patients with leukemia or solid tumor; Neutropenia due to infection or chemotherapy
Exclusion criteria: Patients with drug reaction to investigation drugs; Failure to refer the patients to follow up.
Age
From 1 year old to 16 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Patients, drug injectors and physicians were aware of the drug is injected. There was no possibility blinding of the groups due to difference in drug injection days.
Groups participating in the study were three different groups include 11 subjects were selected from each group. The randomizing in our study is unenforceable.
In this study, 33 patients were enrolled in three different groups according to underlying disease. The patients at two different times under two different treatment and self control groups were considered as individual. Thus overall sample size in this study is equal to 66.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee, Tehran University of Medical Sciences
Street address
Poursina Ave,16th Azar Ave
City
Tehran
Postal code
Approval date
2012-05-12, 1391/02/23
Ethics committee reference number
91.د.2134.130
Health conditions studied
1
Description of health condition studied
Neutropenia
ICD-10 code
D70
ICD-10 code description
Neutropenia
Primary outcomes
1
Description
Absolute Neutrophil Count
Timepoint
A week followig end of treatment
Method of measurement
Laboratory
Secondary outcomes
1
Description
Drug side effect
Timepoint
7 days after treatment
Method of measurement
Physical Examination
Intervention groups
1
Description
Filgrastim, subcutaneously, 5-10 µg/kg, daily, to 7 days
Category
Treatment - Drugs
2
Description
Pegfilgrastim, Ampule subcutaneously,100 µg/kg as a single dose
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Asghar Hospital
Full name of responsible person
Saeed Yousefian
Street address
Zafar Avenue, Modares Avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Cinnagen Drug Corporation
Full name of responsible person
Saeed Yousefian
Street address
5th floor, No 56, Azimi Ave, 1st Phase, Ekbatan Town
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cinnagen Drug Corporation
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
Ali Asghar Hospital
Full name of responsible person
Saeed Yousefian
Position
Fellowship of Pediatric Hematology and Oncology
Other areas of specialty/work
Street address
Zafar Avenue, Modares Avenue
City
Tehran
Postal code
Phone
+98 21 2304 6411
Fax
Email
yousefianــsaeed@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ali Asghar Hospital
Full name of responsible person
Saeed Yousefian
Position
Fellowship of Pediatric Hematology and Oncology
Other areas of specialty/work
Street address
Zafar Avenue, Modares Avenue
City
Tehran
Postal code
Phone
+98 21 2304 6411
Fax
Email
yousefian_saeed@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ali Asghar Hospital
Full name of responsible person
Saeed Yousefian
Position
Fellowship of Pediatric Hematology and Oncology
Other areas of specialty/work
Street address
Zafar Avenue, Modares Avenue
City
Tehran
Postal code
Phone
+98 21 2304 6411
Fax
Email
yousefian_saeed@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)