drugset / Trial / NCT00514813

Dynepo Long-Term Safety Study

NCT00514813 ↗

Phase 4 Terminated 152 enrolled Shire
NaSingle-groupOpen-labelOther

Summary

To assess the incidence rate of Treatment Emergent Adverse Events (TEAEs) over 2 years in patients treated with Dynepo.

Timeline

Start
2007-06-06
Primary completion
2008-07-31
Completion
2008-07-31

Outcome

Outcome not reported

Stopped: “The termination of the study is not linked to a product recall or result of any safety signal. Rather it was sponsor's commercial decision to withdraw the MA”

Drugs

EvaluationDrugModalityDoseRoute
Subject Epoetin delta Protein / enzyme biologic — Subcutaneous