Clinical trial
Safety and Efficacy Study of GCSF Therapy to Treat Patients at High Risk for…
NCT00497809 · AviGenics, Industry · Completed
Key facts
| NCT number | NCT00497809 |
|---|---|
| Title | Safety and Efficacy Study of GCSF Therapy to Treat Patients at High Risk for Chemotherapy Induced Severe Neutropenia |
| Official title | An Open-Label, Dose Finding, Prospective, Multi Center, Randomized, Parallel Group Study to Assess the Efficacy and Safety of Three Different Dose Levels of AVI 014 (G-CSF) Compared With a Standard Dose of Neupogen® in Breast Cancer Patients at High (>20%) Risk for Chemotherapy Induced Severe… |
| Lead sponsor | AviGenics, Industry |
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Breast Cancer, Neutropenia |
| Intervention type | Drug |
| Interventions | AVI-014 versus Filgrastim |
| Enrollment | 189 |
| Start date | Aug 1, 2007 |
| Primary completion | Jul 1, 2008 |
| Completion | Jul 1, 2009 |
| First posted | Jul 9, 2007 |
| Last update posted | May 3, 2011 |
| Countries | India, United States |
At a glance
- 10–99 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: