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The comparison of effects of two drugs in neutropenic patients

Clinical trial of comparison between prophylactic effect of filgrastim and pegfilgrastim on neutropenia caused by chemotherapy of solid tumors in children

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017011131878N1
Enrollment
90
Registered
2017-04-29
Start date
2017-05-04
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

Neutropenia. Neutropenia

Interventions

Intervention 1: Intervention group 1: Group one will be treated with a daily dose of Filgrastim in the first period and Pegfilgrastim in the second, separated by a washout period of at least 30 days.
Treatment - Drugs
Intervention group 1: Group one will be treated with a daily dose of Filgrastim in the first period and Pegfilgrastim in the second, separated by a washout period of at least 30 days. The Filgrastim a
Intervention group 2: Group two will be treated with a daily dose of Pegfilgrastim in the first period and Filgrastim in the second, separated by a washout period of at least 30 days. The Filgrastim a
Control group: Third group will be received no medication.

Sponsors

Vice chancellor for research, Arak University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 15 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Solid tumor confirmed by pathology; Children less than 15 years; Parental consent. Exclusion criteria: Severe infection; Use of Corticosteroid; Sensitivity to filgrastim or pegfilgrastim; Lack of parental consent to continue participating in the study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Absolute Neutrophil Count. Timepoint: Before chemotherapy and the first, third, seventh and fourteenth day after Granulocyte Colony Stimulating Factor (GCSF) administration. Method of measurement: Laboratory.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Aziz Eghbali

Amir-Kabir Hospital

aziz_eghbali@yahoo.com+98 86 3313 5075

Outcome results

None listed

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