drugset / Trial / NCT01193699

Safety Study of Pegylated Interferon Alpha 2b to Treat Polycythemia Vera

NCT01193699

Phase 1/2 Completed 24 enrolled AOP Orphan Pharmaceuticals AG
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is the identification of the maximum tolerated dose (MTD) of the investigational medicinal product. Moreover the safety and tolerability will be assessed and an exploratory analysis of efficacy and biomarker modulation will be performed.

Timeline

Start
2010-08
Primary completion
2018-01-25
Completion
2018-01-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Ropeginterferon alfa-2b Protein / enzyme biologic 50 ug Subcutaneous
Subject Ropeginterferon alfa-2b Protein / enzyme biologic 540 ug Subcutaneous