A Prospective, Single-center Clinical Trial of Pegylated Interferon Alfa-2b Versus Interferon Alfa Therapy in the Treatment of Childhood and Adolescent Essential Thrombocythemia
Who is this study for? Pediatric and young adult patients up to age 19 with essential thrombocythemia
What treatments are being studied? Pegylated interferon alfa-2b
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Eligibility
Participation Requirements
Sex: All
Maximum Age: 19
Healthy Volunteers: f
View:
• \<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
Locations
Other Locations
China
Institute of Hematology & Blood Diseases Hospital
RECRUITING
Tianjin
Contact Information
Primary
Rongfeng Fu, MD
furongfeng@ihcams.ac.cn
+862223909009
Backup
Lei Zhang, MD
zhanglei1@ihcams.ac.cn
+862223909240
Time Frame
Start Date: 2020-01-10
Estimated Completion Date: 2024-11-20
Participants
Target number of participants: 40
Treatments
Active_comparator: Recombinant Interferon Alpha
Recombinant Interferon Alpha, with an initial dose of 300 wu twice a week. Other interferons that have been listed can be used if Recombinant Interferon Alpha (300 wu) is not available, and the specific dose will be determined by the researchers.
Experimental: Pegylated Interferon Alfa-2b
Pegylated Interferon Alfa-2b, with an initial dose of 135 ug once a week (body surface area \< 1.73 m2) or 180 ug once a week ( body surface area≥1.73 m2).
Related Therapeutic Areas
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China