At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 61 enrolled
Drug / intervention
sirolimusdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Study - Clinical Trial Assessing Efficacy and Safety of the mTOR Inhibitor Sirolimus in the Treatment of Complicated Vascular Anomalies
In Brief
A Phase 2 clinical trial evaluating sirolimus for Kaposiform Hemangioendotheliomas and 8 related conditions. Completed, enrolled 61 participants across 2 sites.
Detailed Summary
The purpose of this study is to determine if the use of sirolimus in the treatment of children and young adults with complicated vascular anomalies will prove to be safe and provide objective response resulting in improved clinical status and quality of life. Funding Source - FDA OOPD (Food and Drug Administration - Office of Orphan Products Development)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKaposiform Hemangioendotheliomas, Tufted Angioma, Capillary Venous Lymphatic Malformation, Venous Lymphatic Malformation, Microcystic Lymphatic Malformation, Mucocutaneous Lymphangiomatosis and Thrombocytopenia, Capillary Lymphatic Arterial Venous Malformations, PTEN Overgrowth Syndrome With Vascular Anomaly, Lymphangiectasia Syndromes
CountriesUnited States
CollaboratorsChildren's Hospital Medical Center, Cincinnati
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2009
Enrollment StartOct 2009
Primary CompletionMar 2014
Study CompletionOct 2020
TodayJul 2026
First PostedSep 11, 2009
Enrollment StartOct 1, 2009
Primary CompletionMar 1, 2014
Study CompletionOct 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 16.8 years ago
Interventions
sirolimusdrug
liquid dosing based on trough levels