NCT05549167View on ClinicalTrials.gov

Efficacy and Safety of Sirolimus in Children and Adolescents With Juvenile Nasopharyngeal Angiofibroma (JNA)

PHASE3RecruitingINTERVENTIONAL
Enrollment

117

Participants

Timeline

Start Date

May 30, 2022

Primary Completion Date

September 30, 2029

Study Completion Date

December 30, 2029

Conditions
Juvenile Nasopharyngeal Angiofibroma
Interventions
DRUG

Sirolimus

Sirolimus 0,8 mg/m2, but \<2 mg per day, once a day (QD), per os, oral solution, 1mg/ml, 60 ml Optimal individual dosage of sirolimus will be determined under control of concentration in blood serum. Therapeutic concentration - 5-15 ng/ml. Blood samples will be collected until therapeutic concertation will be achieved in 2 consecutive samples, but no more than 4 samples (on the 4th, 7th, 10th, 14th days of admission).

Trial Locations (1)

117997

RECRUITING

Research Institute of Pediatric Hematology, Oncology and Immunology, Moscow

All Listed Sponsors
lead

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

OTHER