Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552429
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-27
Brief Title:
Peginterferon α-2b Injection for Hydroxyurea Resistant or Intolerant ET
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Multicenter Randomized Open-label Study to Evaluate the Pharmacokinetic Safety and Efficacy of Peginterferon Alfa-2b Injection in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter randomized open-label Phase 2 clinical study It is aimed to enroll 27 essential thrombocytopenia ET patients who are resistant to or intolerant of hydroxyureaHU Eligible patients will be randomized to receive either Peginterferon α-2b 135 mcg or Peginterferon α-2b 180 mcg at a ratio of 12 and all subjects will go through a target treatment period Weeks 1 Week 48 an extension treatment period Weeks 49 Week 96 and a follow-up period Weeks 97 Week 100 Pharmacokinetics safety efficacy will be evaluated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None