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Experimental drug aims to tame overactive platelet production
NCT ID NCT06552429
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests two doses of peginterferon alfa-2b in 27 adults with essential thrombocythemia, a blood disorder causing too many platelets, who did not respond to or could not tolerate standard therapy. Participants receive weekly injections for up to 96 weeks. The study measures how the drug moves through the body, its safety, and whether it helps control platelet counts and reduce disease complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Peginterferon alfa-2b injection
- What this could lead to
- If successful, this could offer a new treatment option for people with essential thrombocythemia who cannot take or do not respond to standard therapy.
- What could go wrong
- This is a small early-phase trial with only 27 participants, so results may not apply broadly. The drug may cause side effects like flu-like symptoms or fatigue, and it is not yet proven to work better than existing treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 27 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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; * Patients with confirmed hydroxyurea resistance or intolerant, as at least one of the following criteria is met: 1. Platelet count remain greater than 600×10\^9 /L after at least 3 months of HU treatment at a dose ≥2g/d (dose ≥2.5 g/d if subject weight \> 80 kg); 2. Platelet count greater than 400\*10\^9/L while white blood cell (WBC) count lower than 2.5\*10\^9/L, or platelet count greater than 400\*10\^9 /L while hemoglobin lower than 100 g/L at any dose of HU; 3. Presence of HU-related toxicities at any dose of HU: e.g. ulcers in legs, or any unacceptable skin mucosal manifestations or fever; * Platelet counts \> 450\*10\^9/L at screening; * Neutrophil count ≥1.0\*10\^9/L at screening; * Haemoglobin ≥11 g/dL at screening for males and 10 g/dL for females at screening; * There is no serious function damage in liver and kidney: total bilirubin ≤1.5 upper limit of normal (ULN), alanine aminotransferase≤2.0 ULN, aspartate aminotransferase≤2.0 ULN, prothrombin time is prolonged by less than 4 seconds, Creatinine clearance ≥50 mL/min (according to Cockcroft-Gault formula) at screening; * Both male and female subjects must agree take an appropriate contraceptive method, including: 1. Male subjects: must agree to use reliable contraception from inform consent until 6 months following the last dose of the study drug. 2. Female subjects: Must meet at least one of the following conditions: i) Women without childbearing potential; ii) Women of childbearing potential: no pregnant or breastfeed, negative in blood pregnancy test within 4 days prior to the first dosing, and must agree to use reliable contraception from inform consent until 6 months following the last dose of the study drug; * Subjects understand the objective, characteristic, method and possible adverse reactions of the study, voluntarily participate in this study, and sign informed consent. Exclusion Criteria: * 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; * Documented autoimmune disease or history of autoimmune disease at screening, e.g. medication un-controlled thyroid dysfunction, autoimmune hepatitis, idiopathic thrombocytopenic purpura, scleroderma, psoriasis, or any autoimmune arthritis; * Clinically significant pulmonary infiltration, infectious pneumonia, and non-infectious pneumonia at screening that, in the investigator's opinion, would jeopardize the safety of the subject or their compliance with the protocol; * Infection with systemic clinical manifestations at screening, e.g., bacteria, fungi, human immunodeficiency virus, excluding hepatitis B and/or C; * Evidence of severe retinopathy, e.g., cytomegalovirus retinitis, symptomatic macular degeneration, or clinically significant eye disease, e.g. due to diabetes mellitus or hypertension; * Diagnosed clinically significant depression or a history of depression and, in the investigator's opinion, previous suicide attempts or at any risk of suicide at screening; * Diagnosed clinically significant neurological disease or a history of clinically significant neurological disease, except for a history of stable cerebral thrombosis or cerebral hemorrhage; * History of any malignancy within 5 years (except stage 0 chronic lymphocytic leukemia, basal cell carcinoma, squamous cell carcinoma, and superficial melanoma); * A history of alcohol or drug abuse within 1 year; * Have used any investigational drug within 4 weeks prior to first dose of investigational drug, or not recovered from the effects of prior investigational drug administration; * Other situations that, in the investigator's opinion, not appropriate for inclusion.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Harbin First Hospital
RECRUITINGHarbin, China
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Henan Cancer Hospital
RECRUITINGHenan, China
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Nanfang Hospital, Southern Medical University
RECRUITINGGuangzhou, China
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Peking Union Hospital, Chinese Academy of Medical Sciences
RECRUITINGBeijing, China
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Peking University People's Hospital
RECRUITINGBeijing, China
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Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITINGShanghai, China
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The First Affiliated Hospital of Zhejiang University School of Medicine
RECRUITINGZhejiang, China
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Union Hospital affiliated to Fujian Medical University
RECRUITINGFujian, China
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