Nadolol for Proliferating Infantile Hemangiomas

NCT01010308 | Completed Phase 2 DMC

• 1 other identifier: 1000014079
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the efficacy and safety of Nadolol in hemangiomas of infancy. The secondary objective is to assess the feasibility of conducting a randomized controlled trial comparing nadolol with corticosteroids and propranolol.

Conditions

Infantile Hemangioma

Keywords

infantile hemangioma; nadolol

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with at least 75% improvement in the extent of the hemangioma

  Baseline, 6months

Secondary Outcomes (3)

• The proportion of subjects with at least 50% improvement in the extent of the hemangiomas

  Baseline and 6 months

• The percentage of patients with >75% improvement in the Nadolol group compared to a historical cohort of patients receiving propranolol.

  6 months

• The correlation between the changes in the levels of angiogenesis markers and clinical response to treatment.

  6 months

Study Arms (3)

Intervention Group:

EXPERIMENTAL

The patients in this study are infants aged 1 month to 1 year of age with head and neck hemangiomas currently causing /or with impending function loss (e.g. vision, airway obstruction, feeding, etc), or hemangiomas currently causing/or with potential for facial disfigurement Infants aged 1 month to 1 year of age with head and neck hemangiomas that received treatment with systemic propranolol in the past 2 years as a control group

Drug: Nadolol

Historical control group

NO INTERVENTION

Ten infants (1-12 months of age) treated with propranolol will be identified from a Dermatology Database. Patients will be considered as controls if they were treated with propranolol before 1 year of age and had digital photography documentation of their hemangioma.

Angiogenesis marker control group

NO INTERVENTION

The angiogenesis marker control group will consist of 6 -10 patients seen in the Dermatology clinic for conditions other than IH and not receiving corticosteroids or beta blockers.

Interventions

Nadolol DRUG

Nadolol will be administered orally at home starting at 0.5 mg/kg/day divided into 2 doses. Weekly, if BP and heart rate are acceptable, the dose will be increased by 0.5 mg/kg/day up to 2 mg/kg/day.

Intervention Group:

Eligibility Criteria

• Age: 1 Month - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Intervention Group
• Infants aged 1 month to 1 year of age with head and neck hemangiomas currently causing /or with impending function loss (e.g. vision, airway obstruction, feeding, etc), or hemangiomas currently causing/or with potential for facial disfigurement.
• Historical Control Group
• Infants aged 1 month to 1 year of age with head and neck hemangiomas that received treatment with systemic propranolol in the past 2 years
• Angiogenesis Marker Control Group
• Infants aged 1 month to 1 year attending dermatology clinic

You may not qualify if:

• Intervention Group
• Patients with PHACES syndrome (proven) or suspected PHACES (plaque like hemangioma awaiting imaging).
• Children with history of hypersensitivity to beta blockers
• Children with personal history or family history of a first degree relative with asthma
• Children with known renal impairment
• Children with known cardiac conditions which may predispose to heart blocks
• Personal history of hypoglycemia
• Children on medications that may interact with beta blockers
• Historical Control Group:
• No digital photography available documenting IHs progression
• Angiogenesis Marker Control Group:
• Children with IH
• Children on beta blocker or systemic corticosteroids

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Hemangioma, Capillary

Interventions

Nadolol

Condition Hierarchy (Ancestors)

Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• Elena Pope, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: November 8, 2009
• First Posted: November 10, 2009
• Study Start: November 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: February 1, 2012
• Last Updated: August 19, 2021

Record last verified: 2021-08

Locations

CA (1)