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Trial Outcomes & Findings for Incidence of Hepatic Hemangiomatosis in Patients With Cutaneous Hemangiomas (NCT NCT00374335)

NCT ID: NCT00374335

Last Updated: 2011-09-16

Results Overview

The number of participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least one large cutaneous hemangioma) who were found to have hepatic hemangiomas on abdominal ultrasound

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

261 participants

Primary outcome timeframe

2 years

Results posted on

2011-09-16

Participant Flow

Participant milestones

Participant milestones
Measure
Group 1
Cutaneous Hemangiomas (multiple \> 5, 1-4, or at least 1 hemangioms \>30 cm2)
Overall Study
STARTED
261
Overall Study
COMPLETED
261
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Incidence of Hepatic Hemangiomatosis in Patients With Cutaneous Hemangiomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Group 1
n=261 Participants
Cutaneous Hemangiomas (multiple \> 5, 1-4, or at least 1 hemangioms \>30 cm2)
Age, Categorical
<=18 years
261 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age Continuous
0.3 years
STANDARD_DEVIATION 0.1 • n=5 Participants
Sex: Female, Male
Female
192 Participants
n=5 Participants
Sex: Female, Male
Male
69 Participants
n=5 Participants
Region of Enrollment
United States
232 participants
n=5 Participants
Region of Enrollment
Spain
13 participants
n=5 Participants
Region of Enrollment
Canada
16 participants
n=5 Participants

PRIMARY outcome

Timeframe: 2 years

The number of participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least one large cutaneous hemangioma) who were found to have hepatic hemangiomas on abdominal ultrasound

Outcome measures

Outcome measures
Measure
Group 1
n=261 Participants
Cutaneous Hemangiomas (multiple \> 5, 1-4, or at least 1 hemangioms \>30 cm2)
Frequency of Hepatic Hemangiomas Identified on Abdominal Ultrasound
24 participants

PRIMARY outcome

Timeframe: 2 years

The number of participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least one large cutaneous hemangioma) who were found to have hepatic hemangiomas on abdominal ultrasound

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Which participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least 1 large cutaneous hemangioma) were found to have hepatic hemangiomas on abdominal ultrasound

Outcome measures

Outcome measures
Measure
Group 1
n=261 Participants
Cutaneous Hemangiomas (multiple \> 5, 1-4, or at least 1 hemangioms \>30 cm2)
Risk Factors Associated With the Development of Hepatic Hemangiomas
24 participants

Adverse Events

Group 1

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. Kimberly Horii

Children's Mercy Hospitals and Clinics

Phone: 816-234-3924

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place