Status:
COMPLETED
Efficacy and Safety of Pegylated Interferon Alfa in Polycythemia Vera
Lead Sponsor:
PV-Nord
Conditions:
Polycythemia Vera
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 administ...
Detailed Description
The aim of PV treatment is to reduce the risk of vascular thrombosis without enhancing the long-term risk of evolution toward myelofibrosis or MDS/AL. Although currently controversial, phlebotomies ha...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00241241
Start Date
September 1 2004
End Date
January 1 2008
Last Update
October 21 2015
Active Locations (5)
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1
Hopital Avicenne
Bobigny, France
2
Hopital Huriez
Lille, France
3
Hopital Dupuytren
Limoges, France
4
Hopital Lariboisiere
Paris, France