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NOT YET RECRUITING
NCT07665177
PHASE4

Abrupt Discontinuation Versus Gradual Tapering of Propranolol in Infantile Hemangioma

Sponsor: West China Hospital

View on ClinicalTrials.gov

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.

Official title: Rebound Growth After Abrupt Discontinuation Versus Gradual Tapering of Propranolol in Infantile Hemangioma: A Multicenter Randomized Noninferiority Trial

Key Details

Gender

All

Age Range

6 Months - 60 Months

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2026-07-01

Completion Date

2028-03-30

Last Updated

2026-06-24

Healthy Volunteers

No

Interventions

DRUG

Abrupt Discontinuation of Propranolol

Propranolol will be stopped immediately once the participant meets predefined discontinuation criteria, including complete or near-complete clinical regression, no obvious blood flow on ultrasound, and maintenance of maximal regression for 3 months.

DRUG

Gradual Tapering of Propranolol

The propranolol dose will be reduced to half of the original total daily dose for the first 2 weeks, then reduced to one quarter of the original total daily dose for another 2 weeks, and propranolol will be discontinued in week 5.

Locations (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China