Propranolol Versus Prednisolone for Treatment of Symptomatic Hemangiomas
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|ClinicalTrials.gov Identifier: NCT00967226|
Recruitment Status : Terminated (Serious adverse events with prednisolone, primarily temporary growth retardation, <5th percentile.)
First Posted : August 27, 2009
Results First Posted : February 24, 2016
Last Update Posted : February 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hemangioma of Infancy||Drug: propranolol Drug: Prednisolone||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Propranolol vs Prednisolone for Infant Hemangiomas-A Clinical and Molecular Study|
|Study Start Date :||July 2009|
|Primary Completion Date :||January 2013|
|Study Completion Date :||December 2014|
Experimental: propranolol for treatment of hemangiomas
Assessing efficacy and tolerability of propranolol in management of symptomatic hemangiomas
propranolol 0.5 mg/kg orally, 4 per day - 4-6 months
Active Comparator: Prednisolone
Assessing efficacy and tolerability of prednisolone in management of symptomatic hemangiomas and comparing to propranolol.
1.0 mg/kg orally, 2 per day 4-6 months
Other Name: pediapred
- Decrease in Size of Hemangioma (Length x Width) in Square mm [ Time Frame: 4-5 months after initiating therapy ]A priori primary outcome was proportional change in the total surface area as measured by lesion's outer margin length x width at baseline minus the same measure at 4 months with surrogate data used at 5 months if 4 months not available.
- Tolerability of Medication [ Time Frame: enrollment until study close out or withdrawal up to 9 months ]All adverse events relating to medication tolerability including: adrenal crisis, growth/development, constitutional (dehydration), allergy/immunology, dermatologic, endocrine, GI, infection, metabolism/labs, pulmonary, vascular.
- Number of Serious Adverse Events (SAEs) [ Time Frame: enrollment until study close out or withdrawal up to 9 months ]Number of serious adverse events experienced by the participants in each treatment arm within the categories adrenal crisis, growth/development, constitutional. Serious adverse events are defined as events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity, or result in a congenital anomaly/birth defect. Other important medical events, based upon appropriate medical judgment, may also be considered Serious Adverse Events if a trial participant's health is at risk and intervention is required to prevent an outcome mentioned.
- Growth and Development Adverse Events [ Time Frame: enrollment to study withdrawal or close out up to 9 months ]Number of Growth and Development AEs in each study arm
- Pulmonary/Respiratory Adverse Events [ Time Frame: enrollment through study close out or withdrawal, up to 9 months ]Number of pulmonary/respiratory adverse events (CTCAE 22) in each study arm
- Allergy/Immunology Adverse Events [ Time Frame: enrollment through study closeout or study withdrawal up to 9 months ]Number of allergy/immunology AE per study arm
- Dermatologic Adverse Events [ Time Frame: enrollment to study close out or withdrawal up to 9 months ]Number of Dermatologic Adverse Events in each study arm.
- Endocrinologic Adverse Events [ Time Frame: enrollment to close out or study withdrawal up to 9 months ]Number of Endocrinologic AEs (of which adrenal crisis does not overlap).
- Gastrointestinal Adverse Events [ Time Frame: enrollment to study withdrawal or study close out up to 9 months ]Number of Gastrointestinal AEs in each arm
- Infectious Adverse Events [ Time Frame: enrollment to study withdrawal or close out up to 9 months ]Number of infectious AEs in each study arm (i.e. conjunctivitis, thrush, fever)
- Metabolic or Laboratory AEs [ Time Frame: enrollment to study withdrawal or close out up to 9 months ]Number of Metabolic or Laboratory AEs in each study arm.
- Vascular Adverse Events [ Time Frame: enrollment to study withdrawal or close out up to 9 months ]Number of Vascular AEs in each study arm.
- Constitutional Adverse Events [ Time Frame: enrollment to study close out or withdrawal up to 9 months ]Number of constitutional AEs in each study arm.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00967226
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20111|
|Principal Investigator:||Nancy M Bauman, MD||Children's Research Institute, Children's National Medical Center|