Comparison of filgrastim produced by Samen Pharmaceutical Company and Neupogen as a standard drug

Comparison of efficacy and adverse effects of filgrastim produced by Samen pharmaceutical company and neupogen as a standard drug in Breast Cancer Patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201206279801N3

Enrollment

168

Registered

2013-12-19

Start date

2013-12-22

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer. Malignant neoplasm of breast

Interventions

Intervention 1: Samen GCSF (5 microgram/kg for 5 days 1 day after chemotherapy). Intervention 2: NEUPOGEN ( 5 microgram/kg for 5 days , 1 day after chemotherapy).

Treatment - Drugs

Samen GCSF (5 microgram/kg for 5 days 1 day after chemotherapy)

NEUPOGEN ( 5 microgram/kg for 5 days , 1 day after chemotherapy)

Eligibility

Sex/Gender

Female

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Age>18 yr; Diagnosis of locally advanced breast cancer; WHO Performance Status less than or equal of 2; Absence of neutropenia (ANC <1500/mm3) before starting chemotherapy; Completing the Consent form. Exclusion criteria: History of hypersensitivity reaction to biologic drugs; Existence of renal failure ; Existence of hepatic failure ; Coadministration of neutropoietic drugs; Existence of cardiac arrythmia.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Duration of neutropenia. Timepoint: between day 1 to day 21 post chemotherapy. Method of measurement: laboratory.	—

Secondary

Measure	Time frame
Frequency of neutropenia episode. Timepoint: between day 1 to 21 post chemotherapy. Method of measurement: laboratory.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohammad Reza Ramezani

Samen Pharmaceutical Co.

dr_ramazani67@yahoo.com+98 511500111

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026