Propranolol Versus Prednisolone for Treatment of Symptomatic Hemangiomas

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Children's Research Institute
Sponsor:
Information provided by (Responsible Party):
Children's Research Institute
ClinicalTrials.gov Identifier:
NCT00967226
First received: August 26, 2009
Last updated: May 25, 2012
Last verified: May 2012
  Purpose

Hemangiomas are relatively common lesions in infants. Most go away spontaneously after one year of life and do not need treatment. Others require treatment because they cause significant symptoms such as pain, or difficulty with breathing, eating or ambulating. Steroids have classically been used to treat hemangiomas and help to shrink them in 1/3 - 2/3 of patients. Unfortunately, steroids have many side effects in babies so physicians have sought other ways to treat them. Recently, the use of propranolol, a heart medication, was serendipitously found to reduce the size of hemangiomas. It appears to have many fewer side effects than steroids but it is not yet known if it works as well as steroids. This study seeks to compare the effect and the side effects of propranolol versus steroids for treating hemangiomas that cause symptoms in infants.


Condition Intervention Phase
Hemangioma of Infancy
Drug: propranolol
Drug: Prednisolone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Propranolol vs Prednisolone for Infant Hemangiomas-A Clinical and Molecular Study

Resource links provided by NLM:


Further study details as provided by Children's Research Institute:

Primary Outcome Measures:
  • reduction in size of hemangioma [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability of medication [ Time Frame: 4-6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: July 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: propranolol for treatment of hemangiomas
Assessing efficacy and tolerability of propranolol in management of symptomatic hemangiomas
Drug: propranolol
propranolol 0.5 mg/kg p.o. QID x 4 - 6 months
Active Comparator: Prednisolone
Assessing efficacy and tolerability of prednisolone in management of symptomatic hemangiomas and comparing to propranolol.
Drug: Prednisolone
1.0 mg/kg p.o. BID x 4-6 months
Other Name: pediapred

Detailed Description:

Infants with symptomatic hemangiomas will be enrolled. Magnetic resonance imaging will be completed before starting medication if the extent of the hemangioma is not evident on clinical examination alone. Infants will be randomized to receive either propranolol or steroids for 4-6 months. Hemangioma response will be measured and compared monthly as will tolerability of the medications. Additionally, urine specimens will be collected at each visit to determine if markers are present that can predict response to therapy.

Additionally, any hemangiomas that are excised will be examined for genetic markers to aid in predicting response to therapy.

  Eligibility

Ages Eligible for Study:   up to 5 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • infants with symptomatic hemangiomas

Exclusion Criteria:

  • asthma
  • diabetes
  • hypertension
  • hypotension
  • hypoglycemia
  • liver failure
  • previous treatment for hemangiomas
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967226

Contacts
Contact: Jennifer Gode, RN 202 476 4270 jgode@cnmc.org
Contact: Nancy Bauman, MD 202 476 4270

Locations
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20111
Contact: Jennifer Gode, RN    202-476-4270    jgode@cnmc.org   
Contact: Nancy Bauman, MD    202 476 4270      
Sponsors and Collaborators
Children's Research Institute
Investigators
Principal Investigator: Nancy M Bauman, MD Children's Research Institute, Children's National Medical Center
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Children's Research Institute
ClinicalTrials.gov Identifier: NCT00967226     History of Changes
Other Study ID Numbers: IRB 4502, NIH grant number 10179326
Study First Received: August 26, 2009
Last Updated: May 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Research Institute:
hemangioma

Additional relevant MeSH terms:
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Propranolol
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 11, 2014