Viewing Study NCT06552429



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