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Abrupt Discontinuation Versus Gradual Tapering of Propranolol in Infantile Hemangioma

NCT07665177 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-06-24

No results posted yet for this study

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.

Conditions

  • Infantile Hemangioma (IH)

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.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
60 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07665177 on ClinicalTrials.gov