Propranolol Versus Prednisolone for Treatment of Symptomatic Hemangiomas - Full Text View

Sponsor:	Children's Research Institute
Information provided by:	Children's Research Institute
ClinicalTrials.gov Identifier:	NCT00967226

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Historical Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Propranolol vs Prednisolone for Infant Hemangiomas-A Clinical and Molecular Study

Resource links provided by NLM:

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Medrol veriderm Methylprednisolone Prednisolone sodium phosphate Propranolol hydrochloride Propranolol Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate Dexpropranolol 6-Methylprednisolone

U.S. FDA Resources

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 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
propranolol for treatment of hemangiomas: Experimental 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
Prednisolone: Active Comparator 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

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

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

Contacts

Contact: linda haga, RN	202 476 5221
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: Linda Haga, RN 202-476-5221
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:

Sánchez Pérez R, Cortes Mora P, González Rodríguez JD, Rodríguez Sánchez F, De la Peña de Torres J. [Treatment of infantile hemangioma with propranolol.] An Pediatr (Barc). 2009 Jul 22; [Epub ahead of print] Spanish. No abstract available.

Denoyelle F, Leboulanger N, Enjolras O, Harris R, Roger G, Garabedian EN. Role of Propranolol in the therapeutic strategy of infantile laryngotracheal hemangioma. Int J Pediatr Otorhinolaryngol. 2009 Aug;73(8):1168-72. Epub 2009 May 29.

Léauté-Labrèze C, Dumas de la Roque E, Hubiche T, Boralevi F, Thambo JB, Taïeb A. Propranolol for severe hemangiomas of infancy. N Engl J Med. 2008 Jun 12;358(24):2649-51. No abstract available.

Responsible Party:	Children's Research Institute ( Nancy M. Bauman MD )
Study ID Numbers:	IRB 4502, NIH grant number 10179326
Study First Received:	August 26, 2009
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00967226 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Research Institute:

hemangioma

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neurotransmitter Agents
Vasodilator Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Methylprednisolone
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Prednisolone acetate
Neuroprotective Agents
Hormones
Propranolol
Therapeutic Uses

Neoplasms, Vascular Tissue
Hemangioma
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Methylprednisolone Hemisuccinate
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Methylprednisolone acetate
Cardiovascular Agents
Antihypertensive Agents
Protective Agents
Glucocorticoids
Pharmacologic Actions
Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010