Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06290765
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-01-26
Brief Title:
Efficacy and Safety of Ropeginterferon Alfa 2b P1101 for Patients With Low-Risk Polycythemia Vera
Sponsor:
PharmaEssentia
Organization:
PharmaEssentia
Study Overview
Official Title:
Efficacy and Safety of Ropeginterferon Alfa 2b P1101 for Patients With Low-Risk Polycythemia Vera - A Randomized Open Label Multicenter Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PV
Brief Summary:
This is a randomized open-label multicenter two-arm study to assess the efficacy and safety of ropeginterferon alfa-2b for patients with low-risk PV Approximately 110 patients with low-risk PV will be enrolled The whole study period is 108 weeks including a main treatment phase 56 weeks an extension treatment phase 48 weeks and a safety follow-up phase four weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None