drugset / Trial / NCT03404752
Pegfilgrastim-gema Compared to Pegfilgrastim-roche for Prevention of Induced Neutropenia in Breast Cancer Patients.
Phase 3
Unknown
120 enrolled
Gema Biotech S.A.
QUID Quality in Drugs and Devices Latin American Consulting SRL · collab
RandomizedParallel-groupSingle-blindPrevention
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.
Timeline
- Start
- 2015-08
- Primary completion
- 2018-06
- Completion
- 2018-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pegfilgrastim | Protein / enzyme biologic | — | — |