Pegylated Interferon Alfa-2b Versus Interferon Alfa Therapy in Childhood and Adolescent Essential… (NCT04226950) | Clinical Trial Compass
UnknownPhase 2
Pegylated Interferon Alfa-2b Versus Interferon Alfa Therapy in Childhood and Adolescent Essential Thrombocythemia
China40 participantsStarted 2020-01-10
Plain-language summary
Objectives: To compare the efficacy and safety in childhood and adolescent patients (\<20 years) diagnosed as essential thrombocythemia treated with the Pegylated Interferon Alfa-2b vs. Interferon Alfa.
Study Design: A prospective, open-label, nonrandomized, single-center clinical trial
Who can participate
Age range19 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 disord…
What they're measuring
1
Change in platelet count
Timeframe: From the start of study treatment (Day 1) up to the end of month 12
Trial details
NCT IDNCT04226950
SponsorInstitute of Hematology & Blood Diseases Hospital, China