Trials / Completed
CompletedNCT01193699
Safety Study of Pegylated Interferon Alpha 2b to Treat Polycythemia Vera
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 Patients With Polycythaemia Vera
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- AOP Orphan Pharmaceuticals AG · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PEG-P-INF alpha-2b (P1101) | µg (starting with 50 µg), subcutaneously, 2-weekly administration |
Timeline
- Start date
- 2010-08-01
- Primary completion
- 2018-01-25
- Completion
- 2018-01-25
- First posted
- 2010-09-02
- Last updated
- 2018-01-30
Locations
6 sites across 1 country: Austria
Source: ClinicalTrials.gov record NCT01193699. Inclusion in this directory is not an endorsement.