Peginterferon α-2b Injection for Hydroxyurea Resistant or Intolerant ET
Recruiting
Phase 2
Interventional Study
Essential Thrombocythemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 27 (estimated)
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd. · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Male or female subjects, aged greater or equal to 18 years old at screening;
* Subjects diagnosed as high-risk ET according to the World Health Organization (WHO) 2016 criteria:1) who is older than 60 years and JAK2V617F positive at screening, 2) or who previously suffered fro…
Contacts