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

NCT01193699 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-01-30

No results posted yet for this study

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

DRUG

PEG-P-INF alpha-2b (P1101)

µg (starting with 50 µg), subcutaneously, 2-weekly administration

Sponsors & Collaborators

  • AOP Orphan Pharmaceuticals AG

    lead INDUSTRY

Principal Investigators

  • Barbara Grohmann-Izay, MD · AOP Orphan Pharmaceuticals AG

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2018-01-25
Completion
2018-01-25

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01193699 on ClinicalTrials.gov