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IRCT2017061234487N1 IRCT 2017-06-29 AryaTinaGene Biopharmaceutical Company A phase III, clinical Trial of Tinapeg(Produced by AryaTinaGene.) versus Neulastim for Preventing Chemotherapy induced Febrile Neutropenia in breast Cancer Patients 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 2017-07-23 anticipated 100 Complete https://irct.ir/trial/26341 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Breast cancer. Intervention 1: Neolastim control drug injection 24 hours after each cycle of chemotherapy. Intervention 2: Tina peg intervention drug injection 24 hours after each cycle of chemotherapy.
public Dr Mohammad Ali Afshari
Karegar Shomali St. Shokrolah St. 103 no. 16.4
Tehran Iran (Islamic Republic of) 1455346878 +98 21 8822 1926 Afshari_ma@yahoo.com AryaTinaGene of knowledge-based company scientific ِDr syed Asadollah Mosavi
Shariati Hospital Oncologhy center
Tehran Iran (Islamic Republic of) 1455346878 +218 6002649 A_mosavi@yahoo.com Blood & Oncologhy research center Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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. no limit no limit Female C50 Breast cancer Treatment - Drugs Treatment - Drugs Neolastim control drug injection 24 hours after each cycle of chemotherapy Tina peg intervention drug injection 24 hours after each cycle of chemotherapy 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. 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. AryaTinaGene Biopharmaceutical Company Approved 2017-05-31 Tehran university of medical science Keshavarz Blv. QODES sT. Tehran Iran (Islamic Republic of) Approved 2017-05-31 Gorgan university of medical science Gorgan Gorgan Iran (Islamic Republic of)