Lymphatic malformation
Conditions
Interventions
Patients take the test drug "Eppikajutsuto" for 6 months. The dose is adjusted according to the body weight of the study subject, and 0.6 g / min 3 per kg of body weight per day is orally administered
Sponsors
Ogawa Keiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagunostic image (at least Echo,CT,MRI)demonstrates a specific LM lesion 2. Weight 25kg or less
Exclusion criteria
Exclusion criteria: When any one or more of the following items are satisfied Has a history of allergic reactions to Eppikajutsuto. Have received or have received mTOR inhibitors Has undergone sclerotherapy / surgery in the past Has a serious disease other than lymphatic malformation Participated in other clinical studies (studies) within 3 months before the start of administration of the test drug Evaluable MRI cannot be taken When the principal investigator or the investigator determines that apatients is inappropriate for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The response of tumor volume due to volumetry of lymphatic malformation at 6 months after drug administration from before the start of administration, volume reduced by 20% at 6 months, and in the case of diffuse lesions, the reduction of major lesions are evaluated in the same manner. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Ratio of volume reduced by 50% or more 2. Reduction rate of lesion 3. 10% improvement of QOL with treatment 4. Safety of administration of Eppikajutsuto 5. Medication adherence of Eppikajutsuto, Ratio of people who could take 70 % or more | — |
Contacts
Public ContactKeiko Ogawa
Hiroshima University hospital
Outcome results
None listed