A phase III, Randomized, two armed, parallel, double blind Controlled non inferiority clinical Trial of Tinapeg(Produced by AryaTinaGene.) versus Neulastim for Preventing Chemotherapy induced Febrile Neutropenia in breast Cancer Patients
This randomized, parallel, double blind controlled non inferiority phase III clinical trial is conducted to compare the effectiveness, safety and tolerability of Tinapeg® (a pegfilgrastim product of AryaTinaGene) versus Neulastim® after 4 cycle of chemotherapy in patients with breast cancer. Twenty four hours after chemotherapy, 100 patients aged 18 to 70 years who have high risk stage 2 or more of breast cancer and need chemotherapy will randomly divided into two groups and subcutaneously will receive Tinapeg® or Neulastim®. Cell blood counts will be performed in the beginning and 14 days after chemotherapy. The side effects and duration of neutropenia and hospitalization due to adverse drug reactions as well as the delay in starting the next cycle of chemotherapy will be recorded. Finally, collected data will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061234487N1
Registration date:2017-06-29, 1396/04/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-06-29, 1396/04/08
Registrant information
Name
Mohammad Ali Afshari
Name of organization / entity
Aria Tinagene of knowledge-based company
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 0556
Email address
skandar@pasteur.ac.ir
Recruitment status
Recruitment complete
Funding source
AryaTinaGene Biopharmaceutical Company
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A phase III, Randomized, two armed, parallel, double blind Controlled non inferiority clinical Trial of Tinapeg(Produced by AryaTinaGene.) versus Neulastim for Preventing Chemotherapy induced Febrile Neutropenia in breast Cancer Patients
Public title
A phase III, clinical Trial of Tinapeg(Produced by AryaTinaGene.) versus Neulastim for Preventing Chemotherapy induced Febrile Neutropenia in breast Cancer Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Prevention
Inclusion criteria for patients in detail, is defined as follows 1. Confirm the diagnosis of breast cancer pathology 2- 1-4 stage diagnosed by NCCN guideline requires chemotherapy regimens have AC. 3. Age between 18 to 70 years 4. The probability of pregnancy in female patients who have them must somehow fit during pregnancy, they avoid chemotherapy (using reliable contraception). Postmenopausal women at least 12 months have passed menopause, they do not need to take care of contraception. 5. Lack of symptomatic infection and fever specialist physician colleague 6. Adequate bone marrow activity is defined as follows: leukocytes >/=3,000/µl absolute neutrophil count >/=1,500/µl hemoglobin >/=8.0g/dl platelets >/=100,000/µl total bilirubin and serum creatinine must be < 1.5 mg/dl. 7. Adequate ability to read and understand the informed consent and to enter the study voluntarily and to sign the form.
Exclusion criteria for patients in detail, is defined as follows: 1. The patient has received systemic chemotherapy before entering the study. 2. Undergoing major surgery during the past 4 weeks. 3. History of uncontrolled seizures, coma, psychological disorders or any other disorder that may decrease the patient ability to decide and sign the form. 4. Presence of any serious and uncontrolled diseases such as active infection, congestive heart failure, variant angina pectoris, cardiac arrhythmia. 5. Pregnancy or breast-feeding.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Tehran university of medical science
Street address
Keshavarz Blv. QODES sT.
City
Tehran
Postal code
1455346878
Approval date
2017-05-31, 1396/03/10
Ethics committee reference number
IR.TUMS.VCR.REC 1396.2481
2
Ethics committee
Name of ethics committee
Gorgan university of medical science
Street address
Gorgan
City
Gorgan
Postal code
1455346878
Approval date
2017-05-31, 1396/03/10
Ethics committee reference number
IR.GOUMS.REC.1396.22
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Breast cancer
Primary outcomes
1
Description
In this clinical trial, equality, the absolute number of neutrophils per cubic millimeter of blood is frequently used as little
Timepoint
14 days after administration of the drug in the 4 cycles of chemotherapy
Method of measurement
blood test
Secondary outcomes
1
Description
1- neutropenic fever (fever over 38.5 degrees for at least an hour, as well as neutropenia less than 500 per cubic millimeter fever occurs on the same day) during each cycle of chemotherapy as well as a total of 4 cycles of chemotherapy. The index at the end of each cycle of chemotherapy in the form of data collection is recorded. 2. The number of days of severe neutropenia.5-severe neutropenia (absolute number of neutrophils less than 500 per microliter) in patients on the thirteenth day of each chemotherapy cycle 6-neutropenic average (absolute number of neutrophils between 500 to 1000 per microliter) in patients on the thirteenth day each cycle of chemotherapy 7-mild neutropenia (absolute neutrophil count 1,000 to 1,500 per microliter) On the thirteenth of each cycle of chemotherapy in patients neutrophil count based on blood samples and 8-cell count measured on the thirteenth day of each chemotherapy cycle, in the form of data collection is recorded.
Timepoint
After each cycle of chemotherapy and 24 hours after administration of study drug
Method of measurement
Tests for blood and neutrophil count
Intervention groups
1
Description
Neolastim control drug injection 24 hours after each cycle of chemotherapy
Category
Treatment - Drugs
2
Description
Tina peg intervention drug injection 24 hours after each cycle of chemotherapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Dr Afshari
Street address
kargar shomali st. shokrollah St. no103
City
Tehran
2
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Dr Afshari
Street address
kargar shomali St. shokrollah St. no103
City
Shiraz
3
Recruitment center
Name of recruitment center
5 Azar Hospital
Full name of responsible person
Dr Afshari
Street address
kargar shomali St. shokrollah St. no103
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
AryaTinaGene Biopharmaceutical Company
Full name of responsible person
Dr Majid Shahbazi
Street address
Sazandegi2 St.
City
Aq Qala
Grant name
111
Grant code / Reference number
110
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
AryaTinaGene Biopharmaceutical 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
AryaTinaGene of knowledge-based company
Full name of responsible person
Dr Mohammad Ali Afshari
Position
PhD
Other areas of specialty/work
Street address
Karegar Shomali St. Shokrolah St. 103 no. 16.4
City
Tehran
Postal code
1455346878
Phone
+98 21 8822 1926
Fax
+98 88631277
Email
Afshari_ma@yahoo.com
Web page address
www.atgbio.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Blood & Oncologhy research center
Full name of responsible person
ِDr syed Asadollah Mosavi
Position
Oncologist
Other areas of specialty/work
Street address
Shariati Hospital Oncologhy center
City
Tehran
Postal code
1455346878
Phone
+218 6002649
Fax
+98 88631277
Email
A_mosavi@yahoo.com
Web page address
www.atgbio.com
Person responsible for updating data
Contact
Name of organization / entity
AryaTinaGene of knowledge-based company
Full name of responsible person
Dr Mohammad ali Afshari
Position
PhD
Other areas of specialty/work
Street address
Karegar Shomali St. Shokrolah St. 103 no. 16.4
City
Tehran
Postal code
1455346878
Phone
+98 21 8863 1277
Fax
+98 88631277
Email
afshari_ma@yahoo.com
Web page address
www.atgbio.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)