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Pegfilgrastim-gema Compared to Pegfilgrastim-roche for Prevention of Induced Neutropenia in Breast Cancer Patients.

NCT03404752 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-01-19

No results posted yet for this study

Summary

This is a randomized, multicentre, Phase 3 study. Patients will be randomly assigned to the Study drug or its comparator. The study will be blinded for the staff members in charge of the endpoint assessment.

Conditions

Interventions

DRUG

Peg-Filgrastim

Sponsors & Collaborators

  • QUID Quality in Drugs and Devices Latin American Consulting SRL

    collaborator OTHER

  • Gema Biotech S.A.

    lead INDUSTRY

Principal Investigators

  • Ezequiel Klimovsky, MD · QUID quality in drugs and devices LATAM consulting SRL

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2018-06-30
Completion
2018-12-31

Countries

  • Argentina

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03404752 on ClinicalTrials.gov