A multicenter, single-arm, prospective study assessing efficacy and safety of the Sirolimus in the Treatment of intractable vascular anomalies
Not Applicable
Recruiting
- Conditions
- Intractable vascular anomalies: Cystic lymphatic malformation, Lymphangiomatosis (Generalized lymphatic anomaly, Kaposiform lymphangiomatosis), Gorham-Stout disease, Kaposiform hemangioendothelioma and Tuffted angioma with Kasabach-Merritt phenomenon, Nenous malformation, Arteriovenous malformation, Klippel-Trenaunay-Weber syndrome,Bluerubber bleb nevus syndrome, Complex-combined vascular malformations
- Registration Number
- JPRN-UMIN000030522
- Lead Sponsor
- Gifu University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients who currently have an uncontrolled infection 2) Uncontrolled diabetes, uncontrolled hypertension, uncontrolled hyperlipidemia, chronic liver disease, or chronic renal disease 3) History of allergy to sirolimus, or additive substance 4) Known history of HIV seropositivity or known immunodeficiency 5) Patients who have undergone surgical resection or interventional radiology procedures for target lesions within 2 weeks 6) Pregnant, probably pregnant, or breast-feeding woman. Patients who do not agree birth control during clinical trial. 7) Patient who is judged inappropriate to participate in this study by the investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse effects and side effects
- Secondary Outcome Measures
Name Time Method Target lesion response rate determined by Independent Review Facility after 24 and 52 weeks of treatments Respiratory function after 24 and 52 weeks of treatments Evaluation of pleural effusion after 24 and 52 weeks of treatments Evaluation of ascites after 24 and 52 weeks of treatments Blood coagulation parameters after 5, 12, 24 and 52 weeks of treatments Bleeding after 24 and 52 weeks of treatments Pain after 24 and 52 weeks of treatments QOL improvement rates after 24 and 52 weeks of treatments ADL improvement rates after 24 and 52 weeks of treatments Laboratory values Vital signs Pharmacokinetics