Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05870475
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-04-10
Brief Title:
Pegylated Interferon α-2b in Combination With Ruxolitinib for Treating Hydroxyurea-resistantIntolerant PV
Sponsor:
Institute of Hematology Blood Diseases Hospital China
Organization:
Institute of Hematology Blood Diseases Hospital China
Study Overview
Official Title:
A Randomized Controlled Study Evaluating the Efficacy and Safety of Pegylated Interferon α-2b in Combination With Ruxolitinib vs Pegylated Interferon α-2b Monotherapy for Treating Hydroxyurea-resistantIntolerant Polycythemia Vera
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Study purpose To compare the efficacy and safety of pegylated interferon α-2b in combination with ruxolitinib versus pegylated interferon α-2b alone for treating hydroxyurea-resistant or hydroxyurea-intolerant polycythemia vera
Detailed Description:
Study purpose To compare the efficacy and safety of pegylated interferon α-2b in combination with ruxolitinib versus pegylated interferon α-2b alone for treating hydroxyurea-resistant or hydroxyurea-intolerant polycythemia vera
The subjects will be randomly divided into two groups
pegylated interferon alpha-2b combined with ruxolitinib group pegylated interferon alpha-2b at a starting dose of 180ug will be administered subcutaneously once a week ruxolitinib at a starting dose of 10mg will be administered orally twice daily
pegylated interferon alpha-2b group pegylated interferon alpha-2b at a starting dose of 180ug will be administered subcutaneously once a week
If complete hematologic remission is not achieved after 12 weeks of treatment with pegylated interferon alpha-2b alone the subject may be switched to the pegylated interferon alpha-2b combined with ruxolitinib group If ruxolitinib is not tolerated the subject may be switched to the pegylated interferon alpha-2b group alone
The subjects will be randomly divided into two groups
pegylated interferon alpha-2b combined with ruxolitinib group pegylated interferon alpha-2b at a starting dose of 180ug will be administered subcutaneously once a week ruxolitinib at a starting dose of 10mg will be administered orally twice daily
pegylated interferon alpha-2b group pegylated interferon alpha-2b at a starting dose of 180ug will be administered subcutaneously once a week
If complete hematologic remission is not achieved after 12 weeks of treatment with pegylated interferon alpha-2b alone the subject may be switched to the pegylated interferon alpha-2b combined with ruxolitinib group If ruxolitinib is not tolerated the subject may be switched to the pegylated interferon alpha-2b group alone
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?:
None
Is an FDA AA801 Violation?:
None