Clinical Trial

Peginterferon α-2b Injection for Hydroxyurea Resistant or Intolerant ET

Recruiting Phase 2
View on ClinicalTrials.gov →
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 hydroxyurea(HU). Eligible patients will be randomized to receive either Peginterferon α-2b 135 mcg or Peginterferon α-2b 180 mcg at a ratio of 1:2, 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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-08-11; most recent amendment 2025-11-13.
Status change: Not Yet Recruiting → Recruiting 2024-12-01
Trial Details
NCT Number NCT06552429
Lead Sponsor Xiamen Amoytop Biotech Co., Ltd.
Conditions Essential Thrombocythemia
Enrollment 27 participants
Start Date 2024-08-29
Primary Completion 2025-10-26 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2025-11-17