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 groupsSponsors and collaborators
Source ClinicalTrials.gov