Nadolol Versus Propranolol in Children With Infantile Hemangiomas

PHASE3CompletedINTERVENTIONAL
Enrollment

74

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

April 30, 2020

Study Completion Date

June 30, 2020

Conditions
Infantile Hemangioma
Interventions
DRUG

Nadolol

"Patients will be administered twice-daily doses of medication as follows: since Day 0- 0.5 mg/kg/day ; since Day 7-1.0 mg/kg/day and since Day 14- 1.5 mg/kg/day. In all subsequent visits the dosage will be adjusted based on the current weight rather than the baseline weight to maintain 1.5 mg/kg/day. Or the dose may be escalated (by 0.5 mg/kg/day at any following study visit) up to 3 mg/kg/day based on the clinical response to maintain the dose that led to at least 75% reduction in the hemangioma size until Week 24, when unblinding happen. At Week 24 paticipants can start weaning by 10% per week or continue with the last dose, depending on the investigator's decision.~S/he will be monitored until Week 52."

DRUG

Propranolol

"Patients will be administered twice-daily doses of medication as follows: since Day 0- 0.5 mg/kg/day ; since Day 7-1.0 mg/kg/day and since Day 14- 1.5 mg/kg/day.~In all subsequent visits the dosage will be adjusted based on the current weight rather than the baseline weight to maintain 1.5 mg/kg/day. Or the dose may be increased by investigator, based on clinical response by 0.5 mg/kg/day at any study visit (up to 3 mg/kg/day divided twice a day) to maintain the dose that lead to at least 75% reduction in the hemangioma size until Week 24, when unblinding happen. At Week 24 paticipants can start weaning by 10% per week or continue with the last dose, depending on the investigator's decision.~S/he will be monitored until Week 52."

Trial Locations (1)

M5G1X8

The Hospital for Sick Children, Toronto

All Listed Sponsors
lead

The Hospital for Sick Children

OTHER

NCT02505971 - Nadolol Versus Propranolol in Children With Infantile Hemangiomas | Biotech Hunter | Biotech Hunter