|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
2 November 2015 |
|
Main ID: |
NCT00241241 |
|
Date of registration:
|
17/10/2005 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Efficacy and Safety of Pegylated Interferon Alfa in Polycythemia Vera
|
|
Scientific title:
|
Multicenter Phase 2 Study of Efficacy and Safety of Pegylated Interferon-alfa 2a in Polycythemia Vera Patients |
|
Date of first enrolment:
|
September 2004 |
|
Target sample size:
|
40 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00241241 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Jean-Jacques Kiladjian, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
PV-Nord |
|
|
Name:
|
Sylvia Bellucci, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
PV-Nord |
|
|
Name:
|
Bruno Cassinat, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
PV-Nord |
|
|
Name:
|
Christine Chomienne, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
PV-Nord |
|
|
Name:
|
Philippe Rousselot, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
PV-Nord |
|
|
Name:
|
Jean-Francois Bernard, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
PV-Nord |
|
|
Name:
|
Pierre Fenaux, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
PV-Nord |
|
|
Name:
|
Marie-Jose Grange, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
PV-Nord |
|
|
Name:
|
Nathalie Cambier, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
PV-Nord |
|
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Polycythemia Vera
|
|
Intervention(s)
|
|
Drug: pegylated interferon-alfa 2a
|
|
Primary Outcome(s)
|
|
response rate after one year of treatment
|
|
Secondary Outcome(s)
|
|
safety
|
|
molecular response
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|