Efficacy and Safety of Pegylated Interferon Alfa in Polycythemia Vera

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Interferon alfa is an effective treatment of polycythemia vera (PV), but about 20% of patients discontinue their treatment because of side effects and treatment schedule (three times per week administration). The pegylated form of interferon alfa-2a has shown a better tolerance in hepatitis patients and is administered only once a week. The purpose of this study is to determine efficacy and safety of pegylated interferon alfa-2a in the treatment of PV patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PV-Nord
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a

Criteria

Inclusion Criteria:

• polycythemia vera diagnosed according to PVSG criteria, modified by Pearson

• Previously untreated patients or patients treated by phlebotomy only or HU or pipobroman for less than 2 years

• Age 18 to 65 years

• Signed informed consent

Exclusion Criteria:

• Contra indication for interferon

• Severe renal or liver disease

• ECOG performance status > 2

• Pregnancy

• Uncontrolled endocrine disorders except well regulated hyperthyroidism and diabetes

• Severe concomitant heart failure or psychiatric disorder

• Patients receiving an other investigational treatment