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Safety and Efficacy Study of Sirolimus in Complicated Vascular Anomalies

NCT00975819 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2026-01-06

Study results available
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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)

Conditions

  • Kaposiform 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

Interventions

DRUG

sirolimus

liquid dosing based on trough levels

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • Denise Martin Adams

    lead OTHER

Principal Investigators

  • Denise M Adams, MD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
31 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2014-03-31
Completion
2020-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00975819 on ClinicalTrials.gov