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New treatment option for Essential Thrombocythemia
Official title Peginterferon α-2b Injection for Hydroxyurea Resistant or Intolerant ET
ClinicalTrials.gov ID: NCT06552429
What this study is testing
What is Peginterferon α-2b injection?
Peginterferon α-2b injection is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for essential thrombocythemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female people, aged greater or equal to 18 years old at screening;
- people diagnosed as high-risk ET according to the World Health Organization (WHO) 2016 criteria：1) who is older than 60 years and JAK2V617F positive...
- people 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...
- Interferon treatment-naïve, and for those who have previously received interferon the the time interval between the last dose of interferon and...
- Patients with confirmed hydroxyurea resistance or intolerant, as at least one of the following criteria is met:
You likely can't join if
- 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...
- History of major organ transplantation;
- Documented autoimmune disease or history of autoimmune disease at screening, e.g. medication un-controlled thyroid dysfunction, autoimmune hepatitis...
- Clinically significant pulmonary infiltration, infectious pneumonia, and non-infectious pneumonia at screening that, in the investigator's opinion...
See the full eligibility criteria
- Male or female people, aged greater or equal to 18 years old at screening;
- people 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...
- people 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:
- 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);
- 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;
- 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...
- Both male and female people must agree take an appropriate contraceptive method, including:
- Male people: must agree to use reliable contraception from inform consent until 6 months following the last dose of the study drug.
- Female people: 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...
- people understand the objective, characteristic, method and possible adverse reactions of the study, voluntarily participate in this study, and sign informed consent.
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Fujian, China
- Guangzhou, China
- Harbin, China
- Henan, China
- Shanghai, China
- Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Fujian, China; Guangzhou, China; Harbin, China; Henan, China; Shanghai, China and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.