Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Peginterferon α-2b injection

    Drug

    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).

  • Peginterferon α-2b injection

    Drug

    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).

Treatment groups

27 Participants
are divided into 2 treatment groups
Group A: Peginterferon α-2b 135 mcg dose groupExperimental treatment 1 intervention
Group B: Peginterferon α-2b 180 mcg dose groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum concentration (Cmax)

Time frame
week1,4, 8, 12, 24, 36, 48, 60, 72, 84, 96.
2

Time to maximum concentration (Tmax)

Time frame
week1,4, 8, 12, 24, 36, 48, 60, 72, 84, 96.
3

Area under the plasma concentration-time curve

Time frame
week1,4, 8, 12, 24, 36, 48, 60, 72, 84, 96.
4

Apparent volume of distribution after oral administration (Vz/f)

Time frame
week1,4, 8, 12, 24, 36, 48, 60, 72, 84, 96.

Secondary outcomes

1

Rate of complete hematological remission.

Time frame
Week 24, 36, 48, 60, 72, 84, 96.
2

Platelet counts change from baseline.

Time frame
Week 12, 24, 36, 48, 60, 72, 84, 96.
3

White blood cell counts change from baseline.

Time frame
Week 12, 24, 36, 48, 60, 72, 84, 96.
4

Complete remission rate.

Time frame
Week 24, 36, 48, 60, 72, 84, 96.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiamen Amoytop Biotech Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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