Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT04226950
Eligibility Criteria:
Inclusion Criteria:
* \<20 years old
* Male or Female
* Diagnosis of essential thrombocythemia according to the 2016 WHO criteria.
* Platelet count ≥ 450 × 109 / L for more than 6 months（If the patient has JAK2 V617F, CALR or MPL gene mutation, the history may be less than 6 months）
* Platelet count ≥ 1000 × 109 / L or other therapeutic indications at screening.
* The guardians has provided written informed consent prior to enrollment
Exclusion Criteria:
* Known to meet the criteria for primary myelofibrosis or polycythemia vera by 2016 WHO criteria
* Presence of any life-threatening co-morbidity
* Secondary thrombocytosis
* Familial thrombocytosis
* Resistance, or intolerance, or any contraindications to interferon
* Interferon is used in the past 1 month before enrollment
* Patients with previous or present thrombosis or active bleeding
* WBC\<4× 109 / L
* HGB\<110g/L
* Poor control of thyroid dysfunction
* Patients with a prior malignancy within the last 3 years
* Patients with severe cardiac or pulmonary dysfunction
* Severe renal damage (creatinine clearance \< 30 ml / min)
* Severe liver dysfunction (ALT or AST \> 2.5×ULN)
* Patients diagnosed as diabetes with poor control
* Patients with hepatitis B virus, hepatitis C virus replication or HIV infection
* Patients with a history of drug / alcohol abuse (within 2 years before the study)
* Patients that have participated in other experimental researches within one month before enrollment
* History of psychiatric disorder
* Any other circumstances that the investigator considers that the patient is not suitable to participate in the trial
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
19 Years
Study:
NCT04226950
Study Brief:
Protocol Section:
NCT04226950