Clinical Trial: Safety Study of Pegylated Interferon Alpha 2b to Treat Polycythemia Vera
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: An Open-label, Prospective, Multicentre, Phase I/II Dose Escalation Study to Determine the Maximum Tolerated Dose and to Assess the Safety and Efficacy of P1101, PEG-Proline-Interferon Alpha-2b in Pat
Brief 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.
Detailed Summary:
Sponsor: AOP Orphan Pharmaceuticals AG
Current Primary Outcome: Maximum tolerated dose (MTD) [ Time Frame: The incidence of dose limiting toxicities (DLTs), which define the MTD are assessed continously until achievement of MTD. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: AOP Orphan Pharmaceuticals AG
Dates:
Date Received: September 1, 2010
Date Started: August 2010
Date Completion: December 2017
Last Updated: December 22, 2016
Last Verified: December 2016