Trial Outcomes & Findings for Hemangioma Associated With High Rates of Morbidity (NCT NCT00394888)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

433 participants

Primary outcome timeframe

2 years

Results posted on

2013-09-20

Participant Flow

Participant milestones

Participant milestones
Measure	Facial Hemangioma Patients with large facial hemangioma.	Lumbosacral Hemangioma Patients with lumbosacral hemangioma.	Multiple Hemangiomas Patients with multiple hemangiomas
Overall Study STARTED	108	48	201
Overall Study COMPLETED	108	48	201
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hemangioma Associated With High Rates of Morbidity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Facial Hemangioma n=108 Participants Patients with large facial hemangioma.	Lumbosacral Hemangioma n=48 Participants Patients with lumbosacral hemangioma.	Multiple Hemangiomas n=201 Participants Patients with multiple hemangiomas	Total n=357 Participants Total of all reporting groups
Age, Categorical <=18 years	108 Participants n=5 Participants	48 Participants n=7 Participants	201 Participants n=5 Participants	357 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age Continuous	0.5 years STANDARD_DEVIATION 1 • n=5 Participants	0.5 years STANDARD_DEVIATION 1 • n=7 Participants	0.5 years STANDARD_DEVIATION 1 • n=5 Participants	0.5 years STANDARD_DEVIATION 1 • n=4 Participants
Sex: Female, Male Female	78 Participants n=5 Participants	33 Participants n=7 Participants	152 Participants n=5 Participants	263 Participants n=4 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	15 Participants n=7 Participants	49 Participants n=5 Participants	94 Participants n=4 Participants
Region of Enrollment United States	108 participants n=5 Participants	48 participants n=7 Participants	201 participants n=5 Participants	357 participants n=4 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	All Participants n=357 Participants entire population count for MRI/A
MRI/MRA of Head/Neck/Chest.	357 participants

PRIMARY outcome

Timeframe: 2 years

Population: Subjects enrolled in the large facial hemangioma arm (n= 108) were analyzed for this outcome measure.

For subjects in the large facial hemangioma arm of the study, a clinical assessment by trained physicians was conducted to determine whether or not each subject met diagnostic criteria for PHACE syndrome.

Outcome measures

Outcome measures
Measure	All Participants n=108 Participants entire population count for MRI/A
Clinical Diagnosis of PHACE Syndrome	33 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Subjects enrolled in the lumbrosacral hemangioma arm (n= 48) were analyzed for this outcome measure

The number of lumbrosacral hemangioma subjects with confirmed spinal abnormalities detected via lumbrosacral MRI.

Outcome measures

Outcome measures
Measure	All Participants n=48 Participants entire population count for MRI/A
Spinal Abnormalities	21 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Subjects diagnosed with clinically definite PHACE syndrome, enrolled in the large facial hemangioma arm (n= 33) were analyzed for this outcome measure.

The number of PHACE subjects identified with cerebrovascular and/or structural brain abnormalities detected using MRI.

Outcome measures

Outcome measures
Measure	All Participants n=33 Participants entire population count for MRI/A
Cerebrovascular and Structural Brain Abnormalities	31 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Subjects diagnosed with clinically definite PHACE syndrome, enrolled in the large facial hemangioma arm (n= 33) were analyzed for this outcome measure.

The number of subjects with clinically definite PHACE syndrome who were identified as having cardiac abnormalities following clinical examination.

Outcome measures

Outcome measures
Measure	All Participants n=33 Participants entire population count for MRI/A
Cardiac Abnormalities Detected Via Clinical Examination	22 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Subjects enrolled in the hepatic hemangioma arm (n= 151) were analyzed for this outcome measure.

The number of participants with multiple (greater than or equal to 5) cutaneous infantile hemangiomas who were found to have hepatic hemangiomas via the us abdominal ultrasound.

Outcome measures

Outcome measures
Measure	All Participants n=151 Participants entire population count for MRI/A
Frequency of Hepatic Hemangiomas Detected Via Abdominal Ultrasound	24 Participants

Adverse Events

Facial Hemangioma

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lumbosacral Hemangioma

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Multiple Hemangiomas

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Beth Drolet

Medical College of Wisconsin

Phone: 414-266-1569

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place