Peginterferon α-2b Injection for Hydroxyurea Resistant or Intolerant ET
ConditionEssential Thrombocythemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorXiamen Amoytop Biotech Co., Ltd.
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), an extension treatment period (Weeks 49 \~ Week 96) and a follow-up period (Weeks 97 \~ Week 100). Pharmacokinetics, safety, efficacy will be evaluated.
Eligibility criteria
Qualifiers
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 from disease-related thrombosis or hemorrhage;
Subjects who have previously received HU for ET, and the time interval between the last HU dose and the first dose of the study drug should not be less than 7 days;
Interferon treatment-naïve, and for those who have previously received interferon the the time interval between the last dose of interferon and randomization should not be less than 1 month;
Disqualifiers
History of any other myeloproliferative tumors, or evidence of the presence of any other myeloproliferative tumors;
Contraindications or hypersensitivities to interferons of any of its excipients;
Severe medical conditions or serious comorbidities that the investigators determined could jeopardize the safety or protocol adherence, e.g. New York Heart Association [NYHA] Class III-IV, congestive heart failure, symptomatic arrhythmias，pulmonary hypertension;
History of major organ transplantation;
Trial design
Treatments tested in this trial
- Peginterferon α-2b injection
- Peginterferon α-2b injection
Treatment groups
27 Participants
are divided into 2 treatment groupsLocations
8Peking 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
Sponsors and collaborators
Xiamen Amoytop Biotech Co., Ltd.
Lead sponsor
Source ClinicalTrials.gov