drugset / Trial / NCT07665177

Abrupt Discontinuation Versus Gradual Tapering of Propranolol in Infantile Hemangioma

NCT07665177

Phase 4 Not yet recruiting 110 enrolled West China Hospital
RandomizedParallel-groupSingle-blindPrevention

Summary

Infantile hemangioma is the most common benign vascular tumor in infancy. Oral propranolol is the first-line systemic treatment for infantile hemangiomas requiring therapy. Although most patients respond well to propranolol, rebound growth may occur after treatment discontinuation, and some patients may require restarting propranolol or receiving additional treatment. In clinical practice, propranolol may be discontinued abruptly after the lesion meets discontinuation criteria, or gradually tapered over several weeks before complete discontinuation. However, high-quality randomized evidence comparing these two discontinuation strategies remains limited. This multicenter randomized noninferiority trial aims to compare the risk of rebound growth after abrupt discontinuation versus gradual tapering of propranolol in patients with infantile hemangioma who have received oral propranolol for at least 6 months and meet predefined discontinuation criteria.

Timeline

Start
2026-07-01
Primary completion
2027-12-30
Completion
2028-03-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Propranolol Small molecule Oral