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RECRUITING
NCT06552429
PHASE2

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

Sponsor: Xiamen Amoytop Biotech Co., Ltd.

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.

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

27

Start Date

2024-08-29

Completion Date

2027-09

Last Updated

2025-11-17

Healthy Volunteers

No

Interventions

DRUG

Peginterferon α-2b injection

Peginterferon α-2b injection, 135 mcg, s.c., once a week, during the targeted treatment period (the first 48 week), peginterferon α-2b dose is depended on the patient's response and tolerability during the extension treatment (week 49 to week 96).

DRUG

Peginterferon α-2b injection

Peginterferon α-2b injection, 180 mcg, s.c., once a week, during the targeted treatment period (the first 48 week), peginterferon α-2b dose is depended on the patient's response and tolerability during the extension treatment (week 49 to week 96).

Locations (8)

Peking Union Hospital, Chinese Academy of Medical Sciences

Beijing, China

Peking University People's Hospital

Beijing, China

Union Hospital affiliated to Fujian Medical University

Fujian, China

Nanfang Hospital, Southern Medical University

Guangzhou, China

Harbin First Hospital

Harbin, China

Henan Cancer Hospital

Henan, China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

The First Affiliated Hospital of Zhejiang University School of Medicine

Zhejiang, China